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This is a Bill, not an Act. For current law, see the Acts databases.
1998-1999-2000-2001
The
Parliament of the
Commonwealth of
Australia
HOUSE OF
REPRESENTATIVES
Presented and read a first
time
Therapeutic
Goods Amendment (Medical Devices) Bill
2001
No. ,
2001
(Health and Aged
Care)
A Bill for an Act to amend the
Therapeutic Goods Act 1989, and for related purposes
ISBN: 0642 468257
Contents
Therapeutic Goods Act
1989 3
Therapeutic Goods Act
1989 97
A Bill for an Act to amend the Therapeutic Goods Act
1989, and for related purposes
The Parliament of Australia enacts:
This Act may be cited as the Therapeutic Goods Amendment (Medical
Devices) Act 2001.
(1) This section and sections 1 and 3 commence on the day on which
this Act receives the Royal Assent.
(2) Subject to subsection (3), Schedule 1 commences on a day to
be fixed by Proclamation.
(3) If Schedule 1 does not commence under subsection (2) within
the period of 6 months beginning on the day on which this Act receives the Royal
Assent, it commences on the first day after the end of that period.
(4) Schedule 2 commences on the fifth anniversary of the day on which
Schedule 1 commences.
Subject to section 2, each Act that is specified in a Schedule to
this Act is amended or repealed as set out in the applicable items in the
Schedule concerned, and any other item in a Schedule to this Act has effect
according to its terms.
1 Part 1 (heading)
Repeal the heading, substitute:
2 Subsection 3(1)
Insert:
accessory means an article that its manufacturer specifically
intended to be used together with a medical device to enable the device to be
used as the manufacturer of the device intended.
3 Subsection 3(1)
Insert:
application audit assessment fee means a fee payable under
subsection 41LA(3).
4 Subsection 3(1)
Insert:
assessment fee means:
(a) a conformity assessment fee; or
(b) an application audit assessment fee;
payable under Part 4-10.
5 Subsection 3(1) (paragraph (b) of the
definition of authorised person)
Omit “Part 5A”, substitute
“Part 6-2”.
6 Subsection 3(1)
Insert:
composite pack has the meaning given by subsection
7B(2).
7 Subsection 3(1) (definition of conformity
assessment certificate)
Repeal the definition, substitute:
conformity assessment certificate means:
(a) in relation to an application for registration or listing of
therapeutic goods under Chapter 3—an attestation of conformity
(within the meaning of the EC Mutual Recognition Agreement or the EFTA Mutual
Recognition Agreement) issued by an approved conformity assessment body;
and
(b) in any other case—a certificate issued under
section 41EE.
8 Subsection 3(1)
Insert:
conformity assessment fee means a fee payable under
subsection 41LA(1).
9 Subsection 3(1)
Insert:
conformity assessment procedures has the meaning given by
section 41DA.
10 Subsection 3(1)
Insert:
conformity assessment standard means a conformity assessment
standard specified in an order under section 41DC.
11 Subsection 3(1)
Insert:
device number, in relation to a medical device, means any
combination of numbers, symbols and letters assigned to the device under
section 41FL.
12 Subsection 3(1)
Insert:
essential principles has the meaning given by
section 41CA.
13 Subsection 3(1)
Insert:
exempt device means a medical device that is of a kind that
is exempted from Division 3 of Part 4-11 by the regulations.
14 Subsection 3(1) (first definition of
exempt goods)
Omit “Part 3”, substitute
“Part 3-2”.
15 Subsection 3(1) (second definition of
exempt goods)
Omit “Part 4”, substitute
“Part 3-3”.
16 Subsection 3(1) (definition of exempt
person)
Omit “Part 4”, substitute
“Part 3-3”.
17 Subsection 3(1)
Insert:
included in the Register, in relation to a medical device to
which Chapter 4 applies, means included in the Register under
Chapter 4.
Note: For medical devices to which Chapter 4 applies,
see section 41BJ.
18 Subsection 3(1)
Insert:
kind, in relation to a medical device, has the meaning given
by section 41BE.
19 Subsection 3(1) (definition of
licence)
Omit “Part 4”, substitute
“Part 3-3”.
20 Subsection 3(1) (definition of
manufacture)
After “therapeutic goods”, insert “that are not medical
devices”.
21 Subsection 3(1)
Insert:
manufacturer, of a medical device, has the meaning given by
section 41BG.
22 Subsection 3(1)
Insert:
medical device has the meaning given by
section 41BD.
23 Subsection 3(1)
Insert:
medical device classification means a classification
specified in the regulations made for the purposes of
section 41DB.
24 Subsection 3(1)
Insert:
medical device standard, in relation to a kind of medical
device, means a medical device standard, specified in an order under
section 41CB, that is applicable to that kind of medical device.
25 Subsection 3(1)
Insert:
refurbishment has the meaning given by the
regulations.
26 Subsection 3(1) (definition of
Register)
Omit “section 17”, substitute
“section 9A”.
27 Subsection 3(1)
Insert:
system or procedure pack has the meaning given by
section 41BF.
28 Subsection 3(1) (definition of therapeutic
goods)
After “and includes”, insert “medical devices
and”.
29 Subsection 3(6)
Omit “or an annual licensing charge”, substitute “, an
annual charge for inclusion in the Register or an annual licensing
charge”.
30 After subsection 4(1)
Insert:
(1A) The reference in paragraph (1)(a) to the efficacy of therapeutic
goods is a reference, if the goods are medical devices, to the performance of
the devices as the manufacturer intended.
31 Subsection 6A(5)
Omit “Part 5”, substitute
“Part 6-1”.
32 At the end of subsection
6A(8)
Add:
; or (c) in the part of the Register for medical devices included under
Chapter 4.
33 At the end of
section 7
Add:
(4) If a declaration under this section:
(a) is a declaration that particular goods or classes of goods are not
therapeutic goods; and
(b) applies wholly or partly to goods that, apart from this section, would
be medical devices;
the goods are not medical devices, or are not medical devices when used,
advertised, or presented for supply in the way specified in the
declaration.
34 Paragraph 7B(1)(b)
Omit “Part 3”, substitute
“Part 3-2”.
35 Paragraph 7B(1)(c)
After “composite pack”, insert “or a system or procedure
pack”.
36 Paragraph 7B(2)(b)
After “contain any”, insert “medical devices
or”.
37 After section 9
Insert:
(1) The Secretary is to cause to be maintained a register, to be known as
the Australian Register of Therapeutic Goods, for the purpose of compiling
information in relation to, and providing for evaluation of, therapeutic goods
for use in humans.
(2) Subject to subsection (3), the Register is to be kept in such
form as the Secretary determines.
(3) The Register is to contain these 3 parts:
(a) a part for goods to be known as registered goods; and
(b) a part for goods to be known as listed goods; and
(c) a part for medical devices included in the Register under
Chapter 4.
(4) The regulations may prescribe:
(a) the therapeutic goods, or the classes of therapeutic goods, that are
required to be included in each part of the Register; and
(b) the ways in which:
(i) goods that are included in the part of the Register relating to
registered goods may be transferred, or may be required to be transferred, to
the part of the Register for listed goods; and
(ii) goods that are included in the part of the Register relating to
listed goods may be transferred, or may be required to be transferred, to the
part of the Register for registered goods; and
(c) the ways in which goods that have been assigned a registration or
listing number may be assigned a different registration or listing number;
and
(d) the ways in which medical devices that have been assigned a device
number may be assigned a different device number.
(5) The Minister may, by notice published in the Gazette, require
that specified therapeutic goods be included in the part of the Register for
listed goods.
(6) If the regulations are amended to require any of those goods to be
included in the part of the Register for listed or registered goods, then the
Gazette notice ceases to have effect in respect of the goods included in
the regulations.
(1) The registration or listing of a medical device to which subsection
15A(5) applied is taken to be cancelled:
(a) on the second anniversary of the day on which Chapter 4
commences; or
(b) if the medical device is of a kind included in the Register under
Chapter 4 before that second anniversary—when that inclusion takes
effect.
(2) The registration or listing of any other medical device is taken to be
cancelled:
(a) on the fifth anniversary of the day on which Chapter 4 commences;
or
(b) if the medical device is of a kind included in the Register under
Chapter 4 before that fifth anniversary—when that inclusion takes
effect.
(3) This section does not prevent the Secretary from taking action under
section 30.
(1) The Register is not open for public inspection, but a person in
relation to whom therapeutic goods are entered on the Register may make a
written request to the Secretary for a copy of the entry in the Register in
relation to the goods.
(2) If the person makes such a request, the Secretary must send to the
person a copy of so much (if any) of that entry as is contained in any computer
database maintained by the Department for purposes connected with the
administration of this Act (other than any part of that entry that was supplied
in confidence by another person).
(3) If the person makes such a request, then, instead of providing a copy
of an entry to the person, the Secretary may, if the request is for the
provision of an electronic copy, provide the information contained in the
entry:
(a) on a data processing device; or
(b) by way of electronic transmission.
(1) The Secretary may:
(a) following a request by a person in relation to whom therapeutic goods
are entered on the Register; or
(b) on the Secretary’s own initiative;
vary the entry in the Register in relation to the goods if the entry
contains information that is incomplete or incorrect.
(2) If:
(a) the person in relation to whom therapeutic goods are registered or
listed has requested the Secretary to vary product information included in the
entry in the Register that relates to the goods; and
(b) the only effect of the variation would be:
(i) to reduce the class of persons for whom the goods are suitable;
or
(ii) to add a warning, or precaution, that does not include any comparison
of the goods with any other therapeutic goods by reference to quality, safety or
efficacy;
the Secretary must vary the entry in accordance with the request.
(3) If:
(a) the person in relation to whom therapeutic goods are registered or
listed has requested the Secretary to vary information included in the entry in
the Register that relates to the goods; and
(b) subsection (2) does not apply to the request; and
(c) the Secretary is satisfied that the variation requested does not
indicate any reduction in the quality, safety or efficacy of the goods for the
purposes for which they are to be used;
the Secretary may vary the entry in accordance with the request.
(4) If:
(a) particular therapeutic goods cease to be medical devices because of a
declaration under subsection 41BD(3); and
(b) those goods are included in the Register under Chapter 4 as a
kind of medical device;
the Secretary must move the entry relating to the goods from the part of
the Register for medical devices to the part for goods to be known as registered
goods or to the part for goods to be known as listed goods (whichever is
applicable).
(5) In this section:
product information, in relation to therapeutic goods, means
information relating to the safe and effective use of the goods, including
information regarding the usefulness and limitations of the goods.
Note: Variations to the Register also occur to give effect
to limited cancellations of entries of kinds of medical devices from the
Register: see subsection 41GO(2).
The Secretary must, at least once every 12 months, publish a list of the
therapeutic goods included in the Register.
38 Transitional for publication of list of goods
on Register
The first list published under section 9E of the Therapeutic Goods
Act 1989 after the commencement of this Schedule must be published within 12
months after the last list published under section 33 of the Therapeutic
Goods Act 1989.
39 Part 2 (heading)
Repeal the heading, substitute:
Note: For 5 years following the commencement of
Chapter 4 (Medical devices), this Chapter will still apply to medical
devices that are registered or listed goods.
40 Subparagraph
10(2)(a)(vii)
Omit “Standards Association of Australia”, substitute
“Standards Australia International Limited”.
41 After section 10
Insert:
A standard under section 10 does not apply to a medical device
unless Part 3-2 applies to the device.
Note: Section 15A sets out when Part 3-2 applies
to a medical device.
42 Part 3 (heading)
Repeal the heading, substitute:
43 Before section 16
Insert:
The general rule
(1) This Part does not apply to a medical device unless this section
provides otherwise.
Previously registered or listed devices
(2) If a medical device is registered goods or listed goods before the
commencement of this section, this Part continues to apply to the device unless
the registration or listing is cancelled.
Note: A registration or listing can be cancelled under
section 30, or can be taken to be cancelled under
section 9B.
Pending applications
(3) This Part continues to apply to a medical device if:
(a) before the commencement of this section, an application was made under
Part 3 for registration or listing of therapeutic goods that include that
medical device; and
(b) immediately before that commencement, the application was not yet
finally determined; and
(c) the application has not been, and is not, withdrawn either before or
after that commencement.
However, this Part ceases to apply to the device if, having been registered
goods or listed goods, the registration or listing is cancelled.
(4) For the purposes of paragraph (3)(b), an application is
finally determined when the application, and any applications for
review or appeals arising out of it, have been finally determined or otherwise
disposed of.
Applications made within 2 years relating to certain medical
devices
(5) This Part applies to a medical device if:
(a) regulations made for the purposes of this section specified
either:
(i) the medical device classification applying to the kind of medical
device that includes that device; or
(ii) medical devices of that kind; and
(b) during the period of 2 years after the commencement of this section,
an application was made under Part 3-2 for registration or listing of
therapeutic goods that include that medical device.
However, this Part ceases to apply to the device if, having been registered
goods or listed goods, the registration or listing is cancelled.
Note: Medical devices that are registered or listed because
of this subsection are taken to be cancelled 2 years after Chapter 4
commences, or before then if medical devices of that kind are included in the
Register under Chapter 4: see subsection 9B(1).
Medical devices that are exempt goods
(6) This Part applies to a medical device, during the period of 2 years
after the commencement of this section, if the device is exempt goods.
Existing approvals under section 19
(7) This Part continues to apply to a medical device if:
(a) an approval or authorisation in force under section 19 applies to
the device; and
(b) that approval or authorisation was in force immediately before the
commencement of this section.
New approvals under section 19
(8) This Part applies to a medical device if:
(a) subsection (7) does not apply to the device; and
(b) during the period of 2 years after the commencement of this section,
an approval is granted or an authorisation is given under section 19 that
applies to the device.
However, this subsection does not apply after the end of that
period.
44 Subsection 16(2)
After “not being”, insert “medical devices
or”.
45 Section 17
Repeal the section.
46 Saving of existing registrations and
listings
(1) Despite the repeal of section 17 of the Therapeutic Goods Act
1989 by item 45, any therapeutic goods that, immediately before the
commencement of this Schedule, were included in the Register are taken to be
included in the Register after that commencement.
(2) Despite the repeal of subsection 17(5) of the Therapeutic Goods Act
1989, any notices that were in force immediately before the commencement of
this Schedule, are taken to have been made under section 9A after that
commencement.
47 Subsection 24B(2)
Repeal the subsection, substitute:
(2) Regulations made for the purposes of subsection (1) may provide
that a person is not allowed to pay an evaluation fee under section 24 by
instalments if any part of an instalment of:
(a) that or any other evaluation fee under section 24 payable by the
person; or
(b) any assessment fee under section 41LA payable by the
person;
was unpaid immediately after the time when it became due for
payment.
48 Paragraphs 25(1)(h) and
(2D)(b)
Omit “Part 4”, substitute
“Part 3-3”.
49 Subsections 25(2B), (2C) and
(2G)
Omit “Part 4” (wherever occurring), substitute
“Part 3-3”.
50 Paragraphs 26(1)(h) and
(2C)(b)
Omit “Part 4”, substitute
“Part 3-3”.
51 Subsections 26(2A), (2B) and
(2F)
Omit “Part 4” (wherever occurring), substitute
“Part 3-3”.
52 Subsections 26A(5) and
(6)
Omit “Part 4” (wherever occurring), substitute
“Part 3-3”.
53 Paragraph 26A(7)(b)
Omit “Part 4”, substitute
“Part 3-3”.
54 Sections 32 and 33
Repeal the sections.
55 Saving of existing requests for inspection or
variation of the Register
(1) A request for a copy of an entry in the Register under section 32
of the Therapeutic Goods Act 1989:
(a) that was made before the commencement of this Schedule; and
(b) that was not dealt with before that commencement;
is taken, after that commencement, to be a request made under
section 9C of the Therapeutic Goods Act 1989 as in force after that
commencement.
(2) A request for a variation of an entry in the Register under
section 32 of the Therapeutic Goods Act 1989:
(a) that was made before the commencement of this Schedule; and
(b) that was not dealt with before that commencement;
is taken, after that commencement, to be a request made under
section 9D of the Therapeutic Goods Act 1989 as in force after that
commencement.
56 Part 4 (heading)
Repeal the heading, substitute:
Note: The heading to section 68 is altered by omitting
“Part 4” and substituting
“Part 3-3”.
57 Before section 34
Insert:
This Part does not apply to a medical device unless Part 3-2 applies
to the device.
Note: Section 15A sets out when Part 3-2 applies
to a medical device.
58 Section 42
Renumber as section 41A.
59 After section 41A (as
renumbered)
Insert:
Note: For 5 years following the commencement of this
Chapter, this Chapter will not apply, and Chapter 3 (Medicines and other
therapeutic goods that are not medical devices) will still apply, to medical
devices that are registered or listed goods.
The purpose of this Chapter is to ensure the safety and satisfactory
performance of medical devices. It does this by:
(a) setting out particular requirements for medical devices; and
(b) establishing administrative processes principally aimed at ensuring
those requirements are met; and
(c) providing for enforcement through a series of offences.
The requirements for medical devices are:
(a) essential principles (that are about the safety and performance
characteristics of medical devices); and
(b) conformity assessment procedures (that are mainly about the
application of quality management systems).
Note: Medical device standards may be made under
Division 2 of Part 4-2, and conformity assessment standards may be
made under Division 2 of Part 4-3, but they are not
requirements.
The administrative processes under this Chapter are:
(a) issuing conformity assessment certificates for some manufacturers of
medical devices; and
(b) including medical devices in the Register; and
(c) suspending or cancelling entries of medical devices from the Register;
and
(d) exempting medical devices from the requirement to be included in the
Register; and
(e) obtaining information about medical devices; and
(f) requiring public notification of problems with medical devices, and
recovery of such devices.
Note: Part 4-10 provides for assessment fees to be
payable in some circumstances.
Part 4-11 contains offences that are aimed at ensuring
that:
(a) the requirements for medical devices are complied with; and
(b) the administrative processes under this Chapter (particularly the
inclusion of medical devices in the Register) are followed.
Note: There are some offences in Parts 4-4 to 4-9. They
generally relate to matters ancillary to administrative processes in those Parts
(e.g. false or misleading statements in applications).
(1) A medical device is:
(a) any instrument, apparatus, appliance, material or other article
(whether used alone or in combination, and including the software necessary for
its proper application) intended, by the person under whose name it is or is to
be supplied, to be used for human beings for the purpose of one or more of the
following:
(i) diagnosis, prevention, monitoring, treatment or alleviation of
disease;
(ii) diagnosis, monitoring, treatment, alleviation of or compensation for
an injury or handicap;
(iii) investigation, replacement or modification of the anatomy or of a
physiological process;
(iv) control of conception;
and that does not achieve its principal intended action in or on the
human body by pharmacological, immunological or metabolic means, but that may be
assisted in its function by such means; or
(b) an accessory to such an instrument, apparatus, appliance, material or
other article.
Note: Declarations under subsection (3) exclude
articles from the scope of this definition. Declarations under section 7
can also have this effect: see subsection 7(4).
(2) For the purposes of paragraph (1)(a), the purpose for which an
article is to be used is to be ascertained from the information supplied, by the
person under whose name the article is or is to be supplied, on or in any one or
more of the following:
(a) the labelling on the article;
(b) the instructions for using the article;
(c) any advertising material relating to the article.
(3) The Secretary may, by order published in the Gazette, declare
that a particular instrument, apparatus, appliance, material or other article,
or that a particular class of instruments, apparatus, appliances, materials or
other articles, are not, for the purposes of this Act, medical
devices.
Note: A declaration under this section does not stop
articles from being therapeutic goods.
(4) A declaration under this section takes effect on the day on which the
declaration is published in the Gazette or on such later day as is
specified in the order.
General
(1) For the purposes of this Chapter, a medical device is taken to be of
the same kind as another medical device if they:
(a) have the same sponsor; and
(b) have the same manufacturer; and
(c) have the same device nomenclature system code (see
subsection (3)); and
(d) have the same medical device classification; and
(e) are the same in relation to such other characteristics as the
regulations prescribe, either generally or in relation to medical devices of the
kind in question.
Unique medical devices
(2) If a medical device is not of the same kind as any other medical
device:
(a) this Chapter applies in relation to the device as if it were a kind of
medical device; and
(b) references in this Chapter to delivering a reasonable number of
samples of the kind of device are taken to be references to delivering the
device.
Device nomenclature codes
(3) The regulations may specify device nomenclature codes for medical
devices.
(1) A package and therapeutic goods in the package are a system or
procedure pack if:
(a) the package and the therapeutic goods are for use as a unit, either in
combination as a system or in a medical or surgical procedure; and
(b) the package contains at least one medical device; and
(c) the package and the therapeutic goods do not constitute a composite
pack.
(2) To avoid doubt, a system or procedure pack is a medical
device.
(1) The manufacturer of a medical device is the person who
is responsible for the design, production, packaging and labelling of the device
before it is supplied under the person’s name, whether or not it is the
person, or another person acting on the person’s behalf, who carries out
those operations.
(2) If subsection (1) does not apply to a medical device, the
manufacturer of the device is the person who, with a view to
supplying the device under the person’s name, does one or more of the
following using ready-made products:
(a) assembles the device;
(b) packages the device;
(c) processes the device;
(d) fully refurbishes the device;
(e) labels the device;
(f) assigns to the device its purpose by means of information supplied, by
the person, on or in any one or more of the following:
(i) the labelling on the device;
(ii) the instructions for using the device;
(iii) any advertising material relating to the device.
(3) However, a person is not the manufacturer of a medical device
if:
(a) the person assembles or adapts the device for an individual patient;
and
(b) the device has already been supplied by another person; and
(c) the assembly or adaptation does not change the purpose intended for
the device by means of information supplied by that other person, on or in any
one or more of the following:
(i) the labelling on the device;
(ii) the instructions for using the device;
(iii) any advertising material relating to the device.
(1) A medical device complies, for the purposes of this Chapter (including
Part 4-11), with the essential principles if and only if it does not
contravene any of the essential principles.
(2) However, a medical device is also taken, for the purposes of this
Chapter (other than Part 4-11), to comply with the essential principles
if:
(a) the medical device complies with one or more medical device standards
that apply to it; and
(b) the medical device contravenes the essential principles only in
respect of a part or parts of the essential principles to which that medical
device standard, or one or more of those medical device standards,
relate.
(3) For the purposes of this section, a medical device standard relates to
a part or parts of the essential principles only if the standard specifies that
part or parts.
(1) A conformity assessment procedure is taken, for the purposes of this
Chapter, not to have been applied to a medical device if:
(a) there has been a contravention of the conformity assessment
procedures; and
(b) the contravention relates, wholly or partly, to that device or its
manufacture.
(2) However, for the purposes of this Chapter (other than Part 4-11),
subsection (1) does not apply if:
(a) the quality management system applied in the manufacture of the
medical device complies with one or more conformity assessment standards that
apply to it; and
(b) the contravention is only in respect of a part or parts of the
conformity assessment procedures to which that conformity assessment standard,
or one or more of those conformity assessment standards, relate.
(3) For the purposes of this section, a conformity assessment standard
relates to a part or parts of the conformity assessment procedures only if the
standard specifies that part or parts.
(1) This Chapter does not apply to a medical device if section 15A
applies to the device, except for purposes connected with:
(a) applications for including the medical device in the Register under
this Chapter; or
(b) including the medical device in the Register under this
Chapter.
Note: Section 15A sets out the circumstances in which
Part 3-2 applies or continues to apply to medical devices.
(2) However, if an exemption under section 34 applied to a medical
device, or the manufacturer of the device, immediately before the commencement
of this Chapter:
(a) Parts 4-3 and 4-4, and Division 2 of Part 4-11, apply
in relation to the device after the end of the period of 2 years after that
commencement; and
(b) Parts 4-8, 4-9 and 4-10, and Divisions 3 and 4 of
Part 4-11, apply in relation to the device, to the extent that they relate
to any of the provisions referred to in paragraph (a), after the end of
that period.
Chapter 2 of the Criminal Code applies to all offences
against this Chapter.
Note: Chapter 2 of the Criminal Code sets out
the general principles of criminal responsibility.
The essential principles set out the requirements relating to the safety
and performance characteristics of medical devices. Compliance with applicable
medical device standards is not required, but it is one way to establish
compliance with essential principles.
Note: Dealing in medical devices that do not comply with the
essential principles may be an offence: see Division 1 of
Part 4-11.
(1) The regulations may set out requirements for medical
devices.
(2) These requirements are to be known as the essential
principles.
(1) The Minister may, by order published in the Gazette, determine
that:
(a) matters specified in the order constitute a medical device standard
for kinds of medical devices identified in the order; and
(b) medical devices of those kinds that comply with the standard are to be
treated as complying with those parts of the essential principles specified in
the standard.
(2) A medical device standard takes effect on the day on which the order
establishing the medical device standard is published in the Gazette or
on such later day as is specified in the order.
(3) A medical device standard is a disallowable instrument for the
purposes of section 46A of the Acts Interpretation Act
1901.
(1) Without limiting the scope of section 41CB, an order establishing
a medical device standard for kinds of medical devices may be specified by
reference to:
(a) the safety or performance characteristics of the devices; or
(b) a monograph in the British Pharmacopoeia, the European Pharmacopoeia
or the United States Pharmacopoeia; or
(c) a monograph in a publication approved by the Minister for the purposes
of this subsection; or
(d) such a monograph as modified in a manner specified in the order;
or
(e) a standard published by a standards organisation; or
(f) such other matters as the Minister thinks fit.
(2) For the purposes of paragraph (1)(e), these are standards
organisations:
(a) Standards Australia International Limited;
(b) the International Organisation for Standardization;
(c) the International Electrotechnical Commission;
(d) the European Committee for Standardization;
(e) the European Committee for Electrotechnical Standardization;
(f) any other organisation declared by the Minister by notice published in
the Gazette.
(1) A medical device standard that:
(a) applies to a kind of medical device; and
(b) is inconsistent with another medical device standard that applies only
to some of the devices of that kind;
is, to the extent of the inconsistency, of no effect in relation to the
devices referred to in paragraph (b).
(2) A medical device standard that applies to a kind of medical device
that consists of a combination of component parts takes precedence over any
medical device standard that applies to the component parts.
The conformity assessment procedures set out the requirements relating to
the application of quality management systems for medical devices, and other
requirements imposed on manufacturers.
Compliance with applicable conformity assessment standards is not required,
but it is one way to establish that one or more parts of the conformity
assessment procedures have been applied to medical devices.
Note 1: Dealing in medical devices that have not had the
conformity assessment procedures applied may be an offence: see Division 2
of Part 4-11.
Note 2: See section 41BI on applying the conformity
assessment procedures.
(1) The regulations may set out requirements relating to the obligations
of manufacturers of medical devices.
(2) These requirements are to be known as the conformity assessment
procedures.
(3) The conformity assessment procedures, or any part of the conformity
assessment procedures, may:
(a) be limited in their application to one or more medical device
classifications; or
(b) apply differently to different medical device classifications,
different kinds of medical devices or different manufacturers.
(4) Without limiting subsection (1), the regulations may relate to
all or any of the following:
(a) application of quality management systems for the manufacture of
medical devices;
(b) certification of compliance with the essential principles, or the
quality management systems for the manufacture of medical devices;
(c) notification of, and assessment of, changes to a manufacturer’s
product range, product design or quality management systems;
(d) declarations to be made by manufacturers of medical devices that
conformity assessment procedures have been applied to the devices;
(e) marks to be affixed to medical devices indicating the application of
the conformity assessment procedures to the devices;
(f) monitoring and inspecting the design of medical devices or the
manufacturing processes for medical devices;
(g) monitoring the performance of medical devices;
(h) corrective action required in relation to the design, manufacture,
packaging, labelling and supply of medical devices;
(i) keeping records of the manufacture of medical devices, the design of
medical devices or the manufacturing processes for medical devices.
The regulations may specify:
(a) classifications, to be known as medical device
classifications, applying to medical devices or kinds of medical
devices; and
(b) matters in relation to the classification of medical devices or kinds
of medical devices.
(1) The Minister may, by order published in the Gazette, determine
that:
(a) matters specified in the order constitute a conformity assessment
standard for quality management systems identified in the order; and
(b) a quality management system that complies with the standard is to be
treated as having had applied to it those parts of the conformity assessment
procedures specified in the standard.
(2) A conformity assessment standard may be limited to particular kinds of
medical devices.
(3) A conformity assessment standard takes effect on the day on which the
order establishing the conformity assessment standard is published in the
Gazette or on such later day as is specified in the order.
(4) A conformity assessment standard is a disallowable instrument for the
purposes of section 46A of the Acts Interpretation Act
1901.
(1) Without limiting the scope of section 41DC, an order establishing
a conformity assessment standard for a kind of medical device may be specified
by reference to:
(a) procedures to be carried out under the quality management systems for
the design, manufacture and final inspection of the devices; or
(b) a standard published by a standards organisation; or
(c) such other matters as the Minister thinks fit.
(2) For the purposes of paragraph (1)(b), these are standards
organisations:
(a) Standards Australia International Limited;
(b) the International Organisation for Standardization;
(c) the European Committee for Standardization;
(d) any
other organisation declared by the Minister by notice published in the
Gazette.
A conformity assessment standard that:
(a) identifies quality management systems to which it applies;
and
(b) is inconsistent with another conformity assessment standard that
applies only to particular kinds of medical devices;
is, to the extent of the inconsistency, of no effect in relation to the
devices referred to in paragraph (b).
The Secretary can issue a conformity assessment certificate (which may be
limited to some medical devices) in respect of a manufacturer of medical
devices, signifying one or more of these:
(a) that relevant quality management systems have been applied to the
device;
(b) the essential principles for the device have been complied
with;
(c) other certification requirements of the conformity assessment
procedures have been met.
Note: A conformity assessment certificate may be required
before a valid application can be made for including a kind of medical device in
the Register under this Chapter: see subsection 41FC(2).
The regulations may prescribe:
(a) kinds of manufacturers in respect of whom a conformity assessment
certificate must be issued before valid applications can be made for kinds of
medical devices, manufactured by those manufacturers, to be included in the
Register; or
(b) kinds of medical devices in respect of which a conformity assessment
certificate must be issued before valid applications can be made for those kinds
of medical devices to be included in the Register.
Note: The regulations may prescribe different levels of fees
for different kinds of manufacturers and medical devices: see subsection
41LA(2).
(1) An application for a conformity assessment certificate must:
(a) be made in accordance with a form approved, in writing, by the
Secretary or in such other manner as is approved, in writing, by the Secretary;
and
(b) be delivered to an office of the Department specified by the
Secretary.
Note: A conformity assessment fee is payable under
section 41LA for consideration of the application.
(2) An application is not effective if:
(a) the prescribed application fee has not been paid; or
(b) the application contains information that is false or misleading in a
material particular.
Note: A person might also be guilty of an offence if the
person makes a statement in an application that is false or misleading in a
material particular: see section 41EI.
(3) An approval of a form may require or permit an application or
information to be given in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
(4) The Secretary may, by written notice given to an applicant for a
conformity assessment certificate, require the applicant to allow an authorised
person, at any reasonable time specified in the notice, to inspect:
(a) the premises (including premises outside Australia) and equipment,
processes and facilities that are being or will be used to manufacture medical
devices of the kind in question; and
(b) any other kinds of medical devices on those premises.
(1) If the application is made in accordance with section 41EB, the
Secretary must decide whether to issue the conformity assessment
certificate.
(2) In deciding whether to issue the certificate, the Secretary must
consider some or all aspects of whether the conformity assessment procedures
relating to one or more of the following have been applied to the medical
device:
(a) the application of quality management systems for the manufacture of
medical devices;
(b) the certification of compliance with the essential
principles;
(c) any other requirement of the conformity assessment procedures
specified in regulations made for the purposes of this subsection.
(1) If the application relates to the issuing of a conformity assessment
certificate in relation to which a period has been prescribed under paragraph
63(2)(dc), a decision on the application must be made within that period, unless
the application lapses under section 41EG.
(2) A failure to make a decision on the application within that period
does not render the Commonwealth, the Secretary or a delegate of the Secretary
liable to a person in respect of loss, damage or injury of any kind caused by,
or arising out of, the failure.
(1) After making a decision whether to issue a conformity assessment
certificate, the Secretary must:
(a) notify the applicant in writing of his or her decision within 20
working days; and
(b) if the decision is not to issue the certificate—state in the
notice the reasons for the decision; and
(c) if the decision is to issue the certificate and all assessment fees
that are due and payable for the application have been paid:
(i) issue the certificate to the manufacturer in relation to whom the
application was made; and
(ii) give the applicant a copy of the certificate (if the applicant is not
the manufacturer).
(2) A conformity assessment certificate must specify whether it
covers:
(a) all medical devices manufactured by the manufacturer; or
(b) only specified medical devices manufactured by the
manufacturer.
(1) The conformity assessment certificate commences on the day specified
for the purpose in the certificate.
(2) A conformity assessment certificate has effect at all times:
(a) unless the certificate is suspended under Division 3;
or
(b) until the end of the period (if any) specified in the certificate;
or
(c) until the certificate is revoked under Division 4.
An application for a conformity assessment certificate lapses
if:
(a) the applicant does not deliver to the office to which the application
was made such information (in a form approved in writing by the Secretary) as
will allow the certificate to be issued; or
(b) the applicant does not comply with a requirement by the Secretary to
deliver to the office to which the application was made a reasonable number of
samples of the kind of medical device to which the application relates;
or
(c) the applicant fails to comply with a notice under section 41JA to
give to the Secretary information relating to a kind of medical device to which
the application relates within a further 10 working days from the day specified
in the notice; or
(d) information given to the Secretary by, or on behalf of, the applicant
in connection with the application, including information given for the purpose
of a notice under section 41JA, is false or misleading in a material
particular; or
(e) the applicant fails to allow an authorised person to carry out any
inspection as required under subsection 41EB(4); or
(f) the applicant fails to pay an assessment fee for the application
within the period, specified in the regulations, after being notified of the
decision to issue a conformity assessment certificate under
section 41EE.
(1) The applicant for an application for a conformity assessment
certificate may give the Secretary written notice that the applicant wishes to
treat the application as having been refused if:
(a) a period is prescribed under paragraph 63(2)(dc) for making a decision
on the application; and
(b) at the end of the period, the applicant has not been notified of a
decision whether to issue the certificate.
(2) The notice may be given at any time before the applicant is notified
of the decision.
(3) If a notice has been given, this Act (except for subsection 60(5)) has
effect as if:
(a) the Secretary had decided not to issue the certificate; and
(b) the Minister had made a decision under subsection 60(3) confirming the
decision of the Secretary; and
(c) the Minister’s decision had been made on the day on which notice
was given to the Secretary.
A person is guilty of an offence if:
(a) the person makes a statement (whether orally, in a document or in any
other way); and
(b) the person knows that the statement is false or misleading in a
material particular; and
(c) the statement is in or in connection with an application for a
conformity assessment certificate.
Maximum penalty: 60 penalty units.
Note: Breaching conditions of the conformity assessment
certificate may lead to suspension or revocation of the certificate (see
Divisions 3 and 4), and may be an offence (see subsection
41MN(2)).
Entry and inspection powers
(1) A conformity assessment certificate is subject to the conditions that
the manufacturer in respect of whom the certificate is issued will:
(a) allow an authorised person:
(i) to enter, at any reasonable time, premises (including premises outside
Australia) at which the person or any other person deals with medical devices of
a kind covered by the certificate; and
(ii) while on those premises, to inspect those premises and medical
devices of that kind at those premises and to take samples of devices of that
kind; and
(iii) to carry out tests, or require tests to be carried out, on the
premises on medical devices of a kind covered by the certificate; and
(b) if requested to do so by an authorised person:
(i) produce to the person such documents relating to devices of that kind,
or to the manufacturer’s quality management system, as the person
requires; and
(ii) allow the person to copy the documents.
Review
(2) A conformity assessment certificate is subject to the condition that
the manufacturer in respect of whom the certificate is issued will cooperate in
any review by the Secretary of the certificate to determine whether the
conformity assessment procedures relating to the following matters have been
applied to the kinds of medical devices covered by the certificate:
(a) the application of quality management systems for the manufacture of
medical devices;
(b) the certification of compliance with the essential
principles;
(c) any other requirement of the conformity assessment procedures
specified in the regulations made for the purposes of subsection
41EC(2).
Notification of substantial changes
(3) A conformity assessment certificate is subject to the condition that
the person in respect of whom the certificate is issued will notify the
Secretary, in writing, of any plan for substantial changes to:
(a) quality management systems; or
(b) the product range covered by those systems; or
(c) the product design of kinds of medical devices;
in respect of which the certificate is issued.
Fees
(4) A conformity assessment certificate is subject to the condition that
the applicant for the certificate will pay a fee, prescribed in the regulations,
for a review under subsection (2), when the fee becomes due and
payable.
(5) The regulations may prescribe different levels of fees for different
kinds of manufacturers and medical devices.
Conditions do not limit other conditions
(6) A condition imposed under this section is in addition to any
conditions imposed under this Division.
If the Secretary issues a conformity assessment certificate in respect of
a manufacturer, the Secretary may, in writing, impose conditions on the
certificate in respect of:
(a) one or more kinds of medical devices covered by the certificate;
or
(b) the manufacturer’s quality management system.
(1) The Secretary may, by written notice given to a manufacturer in
respect of whom a conformity assessment certificate has been issued:
(a) impose new conditions on the certificate in respect of:
(i) one or more kinds of medical devices covered by the certificate;
or
(ii) the manufacturer’s quality management system; or
(b) vary or remove existing conditions.
The power may be exercised at the request of the applicant for the
certificate or on the Secretary’s own initiative.
(2) The imposition or variation of a condition under this section takes
effect:
(a) if the notice states that the action is necessary to prevent imminent
risk of death, serious illness or serious injury—on the day on which the
notice is given to the person; or
(b) in any other case—on the day specified for the purpose in the
notice, being a day not earlier than 20 working days after the notice is given
to the person.
Note: Suspension of a conformity assessment certificate
leads to suspension from the Register of the kinds of medical devices to which
the certificate applied (see subsection 41GF(1)). Applications to include such
devices in the Register are not effective (see paragraph
41FC(2)(c)).
(1) The Secretary may, by written notice given to the person in relation
to whom a conformity assessment certificate is issued, suspend the certificate
if the Secretary is satisfied that it is likely that there are grounds for
revoking the certificate under section 41ET.
(2) The suspension may be limited to some medical devices of that kind, as
specified in the notice.
(3) The notice must specify the period of the suspension. The period must
not exceed 6 months.
Note: The period of the suspension may be extended under
section 41EO.
(1) However, before suspending a conformity assessment certificate, the
Secretary must:
(a) inform the person in writing that the Secretary proposes the
suspension and set out the reasons for it; and
(b) give the person a reasonable opportunity to make submissions to the
Secretary in relation to the proposed suspension.
(2) The Secretary is not to make a decision relating to the proposed
suspension until the Secretary has had regard to any submissions the person
makes under paragraph (1)(b).
(3) This section does not apply if the notice under section 41EM
states that the suspension is necessary to prevent imminent risk of death,
serious illness or serious injury.
(1) The suspension takes effect:
(a) if the notice under section 41EM states that the suspension is
necessary to prevent imminent risk of death, serious illness or serious
injury—on the day on which the notice is given to the person; or
(b) in any other case—on the day specified for the purpose in the
notice, being a day not earlier than 20 working days after the notice is given
to the person.
(2) The suspension has effect until:
(a) the Secretary revokes it under section 41EP; or
(b) the expiry of:
(i) the period specified in the notice under section 41EM;
or
(ii) if the period is extended under subsection (3) of this section,
the period as so extended.
Note: Unless a suspension of a conformity assessment
certificate has been revoked, the certificate is automatically revoked: see
section 41ER.
(3) If a person in relation to whom a kind of medical device is included
in the Register shows that he or she has taken steps to address the grounds for
revoking the certificate under section 41ET, the Secretary may, by written
notice given to the person, extend the period specified in the notice under
section 41EM by a further specified period not exceeding 6
months.
(1) The Secretary must revoke the suspension if the Secretary is satisfied
that:
(a) the ground on which the conformity assessment certificate was
suspended no longer applies; and
(b) there are no other grounds for suspending the certificate.
(2) The Secretary’s power to revoke the suspension may be
exercised:
(a) if:
(i) the manufacturer in relation to whom the conformity assessment
certificate was issued; or
(ii) the person who applied for the certificate (if the applicant was not
the manufacturer);
applies in writing to the Secretary; or
(b) on the Secretary’s own initiative.
(3) After revoking the suspension, the Secretary must, within 20 working
days after the revocation, give written notice of the revocation to the person
in relation to whom the conformity assessment certificate was issued.
(4) If the Secretary decides, after an application is made under
paragraph (2)(a), not to revoke the suspension, the Secretary
must:
(a) notify the applicant in writing of his or her decision within 20
working days after the decision is made; and
(b) state in the notice the reasons for the decision.
(1) This Division does not affect the Secretary’s powers to revoke a
conformity assessment certificate under Division 4.
(2) To the extent that a suspension under this Division relates to a
conformity assessment certificate to which such a revocation relates, the
suspension ceases to have effect.
Note: Revocation of a conformity assessment certificate
leads to cancellation of the entry from the Register of the kinds of medical
devices to which the certificate applied (see paragraph 41GK(b)). Applications
to include such devices in the Register are not effective (see paragraph
41FC(2)(c)).
The Secretary must, by written notice given to the person in relation to
whom a conformity assessment certificate is issued, revoke the certificate
if:
(a) the certificate has been suspended under section 41EM;
and
(b) the period applying to the suspension under subsection 41EM(3) or
41EO(3) (as the case requires) expires before the suspension is revoked under
section 41EP.
The Secretary may, by written notice given to the manufacturer in
relation to whom a conformity assessment certificate is issued, revoke the
certificate if the manufacturer requests in writing the revocation of the
certificate.
(1) The Secretary may, by written notice given to the person in relation
to whom a conformity assessment certificate is issued, revoke the certificate
if:
(a) the conformity assessment procedures have not been applied to medical
devices of a kind to which the certificate applies; or
(b) the manufacturer in relation to whom the certificate is issued refuses
or fails to comply with a condition to which the certificate is subject;
or
(c) the Secretary gives to the person a notice under section 41JA
that requires the person to give to the Secretary information or documents
relating to:
(i) a kind of medical device; or
(ii) a quality management system to which the certificate
applies;
and the person fails to comply with that notice within a further 10
working days from the day specified in that notice; or
(d) the manufacturer in respect of whom the certificate is issued no
longer manufactures any of the kinds of medical devices to which the certificate
applies.
(2) However, before revoking the certificate, the Secretary
must:
(a) inform the person in writing that the Secretary proposes the
revocation and set out the reasons for it; and
(b) give the person a reasonable opportunity to make submissions to the
Secretary in relation to the proposed revocation.
(3) The Secretary is not to make a decision relating to the proposed
revocation until the Secretary has had regard to any submissions the person
makes under paragraph (2)(b).
(1) If the Secretary is satisfied that the ground for revoking a
conformity assessment certificate applies only to:
(a) some of the kinds of medical devices to which the certificate applies;
or
(b) some medical devices of the kinds to which the certificate
applies;
the Secretary must limit the revocation to the medical devices to which
that ground or any other ground for revocation applies.
(2) If the revocation of the certificate is so limited, the Secretary must
vary the certificate so that it no longer applies to the medical devices
referred to in subsection (1).
The Secretary must cause to be published in the Gazette, as soon
as practicable after revoking a conformity assessment certificate, or varying a
conformity assessment certificate under subsection 41EU(2), a notice setting out
particulars of the revocation or variation.
If the Secretary revokes a conformity assessment certificate, or varies a
conformity assessment certificate under subsection 41EU(2), the revocation or
variation has effect:
(a) if the revocation is under section 41ER or 41ES, or the variation
relates to a ground of revocation in section 41ER or 41ES—on the day
on which the notice of revocation or variation is given to the person in
relation to whom the certificate was issued; or
(b) in any other case—on such later day as is specified in the
notice.
Kinds of medical devices can be included in the Register if they comply
with the essential principles, and conformity assessment procedures have been
applied to the kinds of devices (and certain other requirements are complied
with).
Inclusions in the Register are subject to certain automatic conditions and
the Secretary may impose further conditions.
Kinds of medical devices are usually included in the Register automatically
once a proper application is made, together with the required certification.
However, applications may be selected for audit, which involves checking some or
all aspects of the application and certification.
Note 1: In some cases, an application relating to a kind of
medical device will not be effective unless that kind of device is covered by a
conformity assessment certificate under Part 4-4: see paragraph
41FC(2)(c).
Note 2: Dealing in medical devices of a kind not included in
the Register may be an offence: see Division 3 of
Part 4-11.
This diagram shows how this Division applies to an application for a kind
of medical device to be included in the
Register.
(1) An application for a kind of medical device to be included in the
Register must:
(a) be made in accordance with a form approved, in writing, by the
Secretary or in such other manner as is approved, in writing, by the Secretary;
and
(b) be delivered to an office of the Department specified by the
Secretary.
(2) An application is not effective if:
(a) the application is not made in accordance with subsection (1);
or
(b) the prescribed application fee has not been paid; or
(c) regulations made for the purposes of section 41EA require the
manufacturer of the kind of device to have a conformity assessment certificate
relating to the kind of medical device before an application under this section
can be made, and no such certificate is in force; or
(d) the application contains information that is false or misleading in a
material particular.
Note: A person might also be guilty of an offence if the
person makes a statement in an application that is false or misleading in a
material particular: see section 41FE.
(3) An approval of a form may require or permit an application or
information to be given in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
The applicant must certify that:
(a) devices of the kind in question are medical devices; and
(b) devices of that kind are intended for a specified purpose, as
ascertained under subsection 41BD(2); and
(c) the kind of device is correctly classified according to the medical
device classifications; and
(d) devices of that kind comply with the essential principles;
and
(e) the applicant:
(i) has available sufficient information to substantiate that compliance
with the essential principles; or
(ii) has procedures in place, including a written agreement with the
manufacturer of the kind of devices setting out the matters required by the
regulations, to ensure that such information can be obtained from the
manufacturer within the period specified in the regulations; and
(f) an appropriate conformity assessment procedure has been applied to
devices of that kind; and
(g) the applicant:
(i) has available sufficient information to substantiate the application
of those conformity assessment procedures; or
(ii) has procedures in place, including a written agreement with the
manufacturer of the kind of devices setting out the matters required by the
regulations, to ensure that such information can be obtained from the
manufacturer within the period specified in the regulations; and
(h) devices of that kind comply with every requirement (if any) relating
to advertising applicable under the regulations; and
(i) devices of that kind do not contain substances that are prohibited
imports for the purposes of the Customs Act 1901; and
(j) the information included in or with the application is complete and
correct.
Note: See section 41BH on compliance with the essential
principles and section 41BI on applying the conformity assessment
procedures.
A person is guilty of an offence if:
(a) the person makes a statement (whether orally, in a document or in any
other way); and
(b) the person knows that the statement is false or misleading in a
material particular; and
(c) the statement is in or in connection with:
(i) an application for including a kind of medical device in the Register
under this Chapter; or
(ii) a certification or purported certification under
section 41FD.
Maximum penalty: 400 penalty units.
(1) If:
(a) an application is made in accordance with section 41FC for a kind
of medical device to be included in the Register in relation to a person;
and
(b) the requirements of section 41FD have been complied
with;
the Secretary must include the kind of device in the Register in relation
to the person, unless the application has been selected under
section 41FH for audit.
(2) As soon as practicable after the kind of device has been included in
the Register, the Secretary must give to the applicant a certificate of the
inclusion of the kind of device in the Register.
(3) The certificate must specify the day on which the inclusion of the
kind of device in the Register commences.
The Secretary must notify the applicant in writing, within 20 working
days after receiving an application under subsection 41FC(1), if an application
for a kind of medical device to be included in the Register is
unsuccessful.
(1) The Secretary:
(a) must select for auditing any application for a kind of medical device
to be included in the Register that is an application of the kind prescribed by
the regulations; and
(b) may select for auditing any other application for a kind of medical
device to be included in the Register.
Note: An application audit assessment fee is payable in
respect of any application that the Secretary must select for auditing: see
Part 4-10.
(2) If an application is selected for auditing:
(a) the Secretary must, within 20 working days after the application is
made, give the applicant a written notice that:
(i) informs the applicant of the selection; and
(ii) requests the applicant to provide any further information necessary
for the auditing of the application; and
(b) the application must be dealt with under this Subdivision and not
under Subdivision B.
(1) In auditing the application, the Secretary may consider all or some
aspects of one or both of the following matters:
(a) whether the application is in accordance with Subdivision A;
(b) whether matters as to which the applicant has certified under
section 41FD are correct.
(2) The Secretary must decide to include the kind of device to which the
application relates in the Register, in relation to the person to whom the
application relates, if the Secretary is satisfied as to all such aspects
considered in the audit.
(3) The Secretary must decide not to include the kind of device to which
the application relates in the Register if the Secretary is not so
satisfied.
After auditing the application, the Secretary must:
(a) notify the applicant in writing of his or her decision within 20
working days after the decision is made; and
(b) if the decision is not to include the kind of device to which the
application relates in the Register—state in the notice the reasons for
the decision; and
(c) if the decision is to include the kind of device in the Register and
all assessment fees for the application that are due and payable have been
paid:
(i) include the kind of device in the Register, in relation to the person
in relation to whom the application was made; and
(ii) give the applicant a certificate of the inclusion of the kind of
device in the Register.
An application that has been selected for auditing lapses if:
(a) the applicant does not deliver to the office to which the application
was made such information (in a form approved in writing by the Secretary) as
will allow the audit of the application; or
(b) the applicant does not comply with a requirement by the Secretary to
deliver to the office to which the application was made a reasonable number of
samples of the kind of medical device to which the application relates;
or
(c) the applicant fails to comply with a notice under section 41JA to
give information relating to devices of that kind to the Secretary within a
further 10 working days from the day specified in the notice; or
(d) information given to the Secretary by, or on behalf of, the applicant
in connection with the application, including information given for the purpose
of a requirement under section 41JA, is false or misleading in a material
particular; or
(e) the applicant fails to pay an assessment fee for the application
within the period, specified in the regulations, after being notified of the
decision to include the kind of medical device in the Register under
section 41FJ.
If a kind of medical device is included in the Register, the Secretary is
to assign a unique device number to it.
(1) The inclusion of a kind of medical device in the Register commences on
the day specified for the purpose in the certificate under
section 41FF.
(2) The inclusion of a kind of medical device in the Register has effect
at all times:
(a) unless the kind of device is suspended from the Register under
Division 1 of Part 4-6; or
(b) until entry of the kind of device is cancelled from the Register under
Division 2 of Part 4-6.
Note: Breaching conditions of the inclusion of a kind of
medical device in the Register may lead to suspension or cancellation of the
entry of the kind of device from the Register (see Part 4-6), and may be an
offence (see subsection 41MN(1)).
Entry and inspection powers
(1) The inclusion of a kind of medical device in the Register is subject
to the conditions that the person in relation to whom the kind of device is
included in the Register:
(a) allow an authorised person:
(i) to enter, at any reasonable time, any premises (including premises
outside Australia) at which that person or any other person deals with medical
devices of that kind; and
(ii) while on those premises, to inspect those premises and medical
devices of that kind at those premises and to take samples of medical devices of
that kind; and
(b) if requested to do so by an authorised person, produce to the person
such documents relating to devices of that kind as the person requires and allow
the person to copy the documents.
Delivery of samples
(2) The inclusion of a kind of medical device in the Register is subject
to a condition that the person in relation to whom the kind of device is
included in the Register will deliver a reasonable number of samples of the kind
of device if the Secretary so requests:
(a) within the period specified in the request; and
(b) in accordance with any other requirements specified in the
request.
The period specified in the request must include at least 10 working
days.
Availability etc. of information
(3) The inclusion of a kind of medical device in the Register is subject
to conditions that:
(a) at all times while the inclusion in the Register has effect, the
person in relation to whom the kind of device is included in the
Register:
(i) has available sufficient information to substantiate compliance with
the essential principles; or
(ii) has procedures in place, including a written agreement with the
manufacturer of the kind of devices setting out the matters required by the
regulations, to ensure that such information can be obtained from the
manufacturer within the period specified in the regulations; and
(b) at all times while the inclusion in the Register has effect, the
person in relation to whom the kind of device is included in the
Register:
(i) has available sufficient information to substantiate that the
conformity assessment procedures have been applied to the kind of medical
device; or
(ii) has available information relating to changes to the kind of medical
device, the product range, and quality management system, of the manufacturer of
the device; or
(iii) has procedures in place, including a written agreement with the
manufacturer of the kind of devices setting out the matters required by the
regulations, to ensure that such information can be obtained from the
manufacturer within the period specified in the regulations; and
(c) at any time while the inclusion in the Register has effect, the person
in relation to whom the kind of device is included in the Register will, if
asked to do so by the Secretary, give the information to the Secretary;
and
(d) the person in relation to whom the kind of device is included in the
Register will give information of a kind mentioned in subsection 41MP(2) to the
Secretary within the period specified in the regulations; and
(e) the person in relation to whom the kind of device is included in the
Register will give the manufacturer of the kind of medical device information
relevant to:
(i) the manufacturer’s obligations under the conformity assessment
procedures; and
(ii) whether medical devices of that kind comply with the essential
principles.
(4) The regulations may prescribe the amount, standard or kind of
information or evidence required for the purposes of paragraphs (3)(c), (d)
and (e).
Advertising material
(5) The inclusion of a kind of medical device in the Register is subject
to a condition that advertising material relating to medical devices of that
kind is consistent with the intended purpose as certified under
section 41FD.
Conditions do not limit other conditions
(6) A condition imposed under this section is in addition to any
conditions imposed under this Division.
(1) If the Secretary includes a kind of medical device in the Register in
relation to a person, the Secretary may, in writing, impose conditions on the
inclusion of the kind of device in the Register.
(2) Conditions referred to in subsection (1) may relate to:
(a) manufacture of devices of that kind; or
(b) custody, intended purpose, supply, disposal or destruction of devices
of that kind; or
(c) keeping of records relating to devices of that kind, including records
relating to the tracking and location of devices of that kind after their
supply; or
(d) matters dealt with in, or matters additional to matters dealt with in,
the essential principles; or
(e) such other matters relating to devices of that kind as the Secretary
thinks appropriate.
(1) The Secretary may, by written notice given to the person in relation
to whom a kind of medical device is included in the Register:
(a) impose new conditions on including the kind of device in the Register
under this Chapter; or
(b) vary or remove existing conditions.
The power may be exercised at the person’s request or on the
Secretary’s own initiative.
(2) The imposition or variation of a condition under this section takes
effect:
(a) if the notice states that the action is necessary to prevent imminent
risk of death, serious illness or serious injury—on the day on which the
notice is given to the person; or
(b) in any other case—on the day specified for the purpose in the
notice, being a day not earlier than 20 working days after the notice is given
to the person.
Inclusions in the Register may be suspended in certain circumstances, such
as when a conformity assessment certificate is suspended. A kind of medical
device that is suspended is taken not to be included in the Register for most
purposes.
Inclusions in the Register may also be cancelled in certain
circumstances.
(1) The Secretary may, by written notice given to the person in relation
to whom a kind of medical device is included in the Register, suspend the kind
of device from the Register if:
(a) the Secretary is satisfied that:
(i) there is a potential risk of death, serious illness or serious
injury if the kind of device continues to be included in the Register;
and
(ii) it is likely that the person will, within the period of the
suspension, be able to take the action necessary to ensure that the kind of
device would not cause a potential risk of death, serious illness or serious
injury if it were to continue to be included in the Register; or
(b) the Secretary is satisfied that it is likely that there are grounds
for cancelling the entry of the kind of device from the Register under
Division 2 (other than under paragraph 41GL(a) or (d) or
section 41GM).
(2) The suspension may be limited to some medical devices of that kind, as
specified in the notice.
(3) The notice must specify the period of the suspension. The period must
not exceed 6 months.
Note: The period of the suspension may be extended under
section 41GC.
(4) The Secretary must cause to be published in the Gazette, as
soon as practicable after the suspension, a notice setting out particulars of
the suspension.
(1) However, before suspending a kind of medical device from the Register
because it is likely that there are grounds for cancelling the entry of the kind
of device from the Register under section 41GN, the Secretary
must:
(a) inform the person by written notice that the Secretary proposes the
suspension and set out the reasons for it; and
(b) give the person a reasonable opportunity to make submissions to the
Secretary in relation to the proposed suspension.
(2) The Secretary is not to make a decision relating to the proposed
suspension until the Secretary has had regard to any submissions the person
makes under paragraph (1)(b).
(1) The suspension takes effect:
(a) if the notice under subsection 41GA(1) states that the suspension is
necessary to prevent a potential risk of death, serious illness or serious
injury—on the day on which the notice is given to the person; or
(b) in any other case—on the day specified for the purpose in the
notice, being a day not earlier than 20 working days after the notice is given
to the person.
(2) The suspension has effect until:
(a) the Secretary revokes it under section 41GD; or
(b) the end of:
(i) the period specified in the notice under subsection 41GA(3);
or
(ii) if the period is extended under subsection (3) of this section,
the period as so extended.
Note: Unless a suspension of a kind of medical device has
been revoked, the entry of the kind of medical device is automatically cancelled
from the Register: see section 41GK.
(3) If a person in relation to whom a kind of medical device is included
in the Register shows that he or she has taken steps to remove the grounds for
cancelling the entry of the kind of device from the Register under
section 41GN, the Secretary may, by written notice given to the person,
extend the period specified in the notice under subsection 41GA(1) by a further
specified period not exceeding 6 months.
(4) The Secretary must cause to be published in the Gazette, as
soon as practicable after the extension, a notice setting out particulars of the
extension.
(1) The Secretary must revoke the suspension if the Secretary is satisfied
that:
(a) the ground on which the kind of medical device concerned was suspended
from the Register no longer applies; and
(b) there are no other grounds for suspending the kind of device from the
Register.
(2) The Secretary’s power to revoke the suspension may be
exercised:
(a) if the person in relation to whom the kind of medical device concerned
is included in the Register applies in writing to the Secretary; or
(b) on the Secretary’s own initiative.
(3) After revoking the suspension, the Secretary must:
(a) within 20 working days after the revocation, give written notice of
the revocation to the person in relation to whom the kind of medical device
concerned is included in the Register; and
(b) as soon as practicable after the revocation, cause to be published in
the Gazette a notice setting out particulars of the revocation.
(4) If the Secretary decides, after an application is made under
paragraph (2)(a), not to revoke the suspension, the Secretary
must:
(a) notify the applicant in writing of his or her decision within 20
working days after the decision is made; and
(b) state in the notice the reasons for the decision.
(1) The applicant for the suspension to be revoked may give the Secretary
written notice that the applicant wishes to treat the application as having been
refused if:
(a) a period is prescribed under paragraph 63(2)(dd) for the Secretary to
make a decision on the application; and
(b) at the end of the period, the Secretary has not made a
decision.
(2) The notice may be given at any time before the Secretary makes a
decision on the application.
(3) If a notice has been given, this Act (except for subsection 60(5)) has
effect as if:
(a) the Secretary had decided not to revoke the suspension; and
(b) the Minister had made a decision under subsection 60(3) confirming the
decision of the Secretary; and
(c) the Minister’s decision had been made on the day on which notice
was given to the Secretary.
(1) The Secretary may, by written notice given to the person in relation
to whom a kind of medical device is included in the Register, suspend the kind
of device from the Register if the conformity assessment certificate applying to
that kind of device is suspended under Division 3 of
Part 4-4.
(2) If the suspension under Division 3 of Part 4-4 is limited to
some medical devices of that kind, the suspension under this section is taken to
be limited to the same extent.
(3) The Secretary must cause to be published in the Gazette, as
soon as practicable after the suspension, a notice setting out particulars of
the suspension.
(1) The suspension takes effect on the day on which the notice is given to
the person.
(2) The suspension has effect until the Secretary revokes it under
section 41GH.
(1) The Secretary must revoke the suspension if:
(a) the suspension under Division 3 of Part 4-4 ceases to have
effect; and
(b) the Secretary is satisfied that there are no other grounds for
suspending the kind of device from the Register.
. (2) After revoking the suspension, the Secretary must:
(a) within 20 working days after the revocation, give written notice of
the revocation to the person in relation to whom the kind of medical device
concerned is included in the Register; and
(b) as soon as practicable after the revocation, cause to be published in
the Gazette a notice setting out particulars of the revocation.
If all or some medical devices of a particular kind are suspended, they
are taken, for the purposes of this Act (other than Division 2 of
Part 4-5, this Division and Part 4-8), not to be included in the
Register while the suspension has effect.
Note: Dealing in medical devices that are not included in
the Register may be an offence: see Division 3 of
Part 4-11.
(1) This Subdivision does not affect the Secretary’s powers to
cancel the entry of kinds of medical devices from the Register under
Division 2.
(2) To the extent that a suspension under this Division relates to medical
devices to which such a cancellation relates, the suspension ceases to have
effect.
The Secretary must, by written notice given to the person in relation to
whom a kind of medical device is included in the Register, cancel the entry of
the kind of device from the Register if:
(a) the kind of device has been suspended from the Register under
section 41GA, and the period applying to the suspension under subsection
41GA(3) or 41GC(3) (as the case requires) expires before the suspension is
revoked under section 41GD; or
(b) a conformity assessment certificate applying to that kind of device is
revoked under Division 4 of Part 4-4.
The Secretary may, by written notice given to the person in relation to
whom a kind of medical device is included in the Register, cancel the entry of
the kind of device from the Register if:
(a) the Secretary is satisfied that there would be an imminent risk of
death, serious illness or serious injury if the kind of device continues to be
included in the Register; or
(b) devices of that kind are no longer therapeutic goods; or
(c) devices of that kind are no longer medical devices; or
(d) the person requests in writing the cancellation of the entry of the
kind of device from the Register; or
(e) the Secretary is satisfied that a statement made in or in connection
with:
(i) the application for including the kind of device in the Register;
or
(ii) the certification or purported certification under section 41FD
relating to the application;
was false or misleading in a material particular; or
(f) the annual charge payable under subsection 4(1B) of the Therapeutic
Goods (Charges) Act 1989 in respect of the inclusion of the kind of device
in the Register is not paid within 20 working days after it becomes payable;
or
(g) both of the following apply:
(i) under the regulations, an authority constituted by or under the
regulations gives a direction to, or makes a requirement of, the person in
relation to an advertisement of the kind of device to ensure that advertising
complies with the Therapeutic Goods Advertising Code;
(ii) the person does not comply with the direction or requirement;
or
(h) there is a serious breach, involving the kind of device, of the
requirements relating to advertising applicable under the regulations, and the
Secretary is satisfied that:
(i) the breach is significant; and
(ii) as a result of the breach, the presentation of devices of that kind
is misleading to a significant extent.
(1) The Secretary may, by written notice given to the person in relation
to whom a kind of medical device is included in the Register, cancel the entry
of the kind of device from the Register if:
(a) the Secretary gives to the person a notice under section 41JA
requiring the person to give to the Secretary information or documents relating
to the kind of device; and
(b) the notice under section 41JA is given for the purposes of
ascertaining whether the kind of device should have been included in the
Register; and
(c) the person fails to comply with the notice under section 41JA
within a further 10 working days from the day specified in that
notice.
(2) The Secretary may, by written notice given to the person in relation
to whom a kind of medical device is included in the Register, cancel the entry
of the kind of device from the Register if:
(a) the Secretary gives to the person a notice under section 41JA
requiring the person to give to the Secretary information or documents relating
to whether medical devices of that kind are being:
(i) supplied in Australia; or
(ii) imported into Australia; or
(iii) exported from Australia; and
(b) either:
(i) the information or documents given are to the effect that medical
devices of that kind are not being supplied in Australia, imported into
Australia or exported from Australia; or
(ii) the person fails to comply with the notice under section 41JA
within a further 10 working days from the day specified in that
notice.
(1) The Secretary may, by written notice given to the person in relation
to whom a kind of medical device is included in the Register, cancel the entry
of the kind of device from the Register if:
(a) medical devices that were devices of that kind when the kind of device
was included in the Register have changed so those medical devices are no longer
devices of that kind; or
(b) the person in relation to whom the kind of medical device is included
in the Register refuses or fails to comply with a condition to which that
inclusion is subject; or
(c) the Secretary gives to the person a notice under
section 41JA:
(i) that requires the person to give to the Secretary information or
documents relating to the kind of device; and
(ii) in respect of which section 41GM does not apply;
and the person fails to comply with that notice within a further 10
working days from the day specified in that notice; or
(d) the person contravenes subsection 41MP(1) in relation to the kind of
device; or
(e) the Secretary is satisfied that the safety or performance of the kind
of device is unacceptable; or
(f) the Secretary is satisfied that any certification, or part of a
certification, under section 41FD in relation to the application for
inclusion of the kind of device in the Register is incorrect, or is no longer
correct, in a material particular.
Note: The matters that must be certified under
section 41FD include compliance with the essential principles and the
application of conformity assessment procedures, being able to substantiate the
compliance and application, and compliance with advertising
requirements.
(2) However, before cancelling the entry of the kind of device from the
Register, the Secretary must:
(a) inform the person in writing that the Secretary proposes the
cancellation and set out the reasons for it; and
(b) give the person a reasonable opportunity to make submissions to the
Secretary in relation to the proposed cancellation.
(3) The Secretary is not to make a decision relating to the proposed
cancellation until the Secretary has had regard to any submissions the person
makes under paragraph (2)(b).
(1) If the Secretary is satisfied that the ground for cancelling the entry
of a kind of medical device from the Register applies only to some medical
devices of that kind, the Secretary must limit the cancellation to the medical
devices to which that ground or any other ground for cancellation
applies.
(2) If the cancellation of the entry of a kind of medical device from the
Register is limited to some medical devices of that kind, the
Secretary:
(a) must vary the entry in the Register accordingly; and
(b) must not delete the entry from the Register because of the
cancellation.
The Secretary must cause to be published in the Gazette, as soon
as practicable after cancelling an entry from the Register of a kind of medical
device, or of some devices of a particular kind, a notice setting out
particulars of the cancellation.
If the Secretary cancels an entry of a kind of medical device, or some
devices of a particular kind, from the Register, the cancellation has
effect:
(a) if the cancellation is under section 41GK or 41GL—on the
day on which the notice of cancellation is given to the person in relation to
whom the kind of device was included in the Register; or
(b) in any other case—on such later day as is specified in the
notice, being a day not earlier than 20 working days after the notice is given
to the person.
There are 3 kinds of exemptions from the prohibitions in Division 3 of
Part 4-11 on dealing in medical devices that are not included in the
Register:
(a) medical devices exempted under the regulations;
(b) approval for medical devices to be used for special treatment of
individuals or for experimental purposes;
(c) authorisation of particular medical practitioners to supply specified
medical devices.
(1) The regulations may exempt from the operation of Division 3 of
Part 4-11:
(a) all medical devices, except those medical devices of the kinds
prescribed for the purposes of this paragraph; or
(b) specified kinds of medical devices.
Note: Division 3 of Part 4-11 contains offences
relating to dealing in medical devices that are not included in the
Register.
(2) An exemption may be subject to conditions that are prescribed in the
regulations.
Note: Breach of the conditions may be an offence: see
subsection 41MN(3).
(3) An exemption under paragraph (1)(a) has effect only for classes
of persons prescribed in the regulations for the purposes of this
subsection.
(4) If the regulations revoke an exemption, the revocation takes effect on
the day specified. The day must not be earlier than 20 working days after the
day on which the regulations are made.
(1) The Secretary may grant a written approval to a person for:
(a) the importation into Australia; or
(b) the exportation from Australia; or
(c) the supply in Australia;
of a specified medical device or kind of medical device (other than
medical devices included in the Register or exempt devices):
(d) for use in the treatment of another person; or
(e) for use solely for experimental purposes in humans.
(2) The approval may be given subject to conditions specified in the
approval, including a condition relating to charging for medical devices of the
kinds in question.
Note: Breach of the conditions may be an offence: see
subsection 41MN(3).
(3) In addition, the regulations may prescribe conditions that apply to a
person’s approval to use specified kinds of medical devices solely for
experimental purposes in humans. The conditions may relate to one or more of the
following:
(a) the preconditions on another person’s use of devices of those
kinds for those purposes;
(b) the principles to be followed in another person’s use of devices
of those kinds for those purposes;
(c) the monitoring of another person’s use, and the results of that
use, of devices of those kinds for those purposes;
(d) the circumstances in which that other person must cease using devices
of those kinds for those purposes.
(4) An application to use specified medical devices in the treatment of
another person must be accompanied by any information about the devices that is
required by the Secretary.
(5) An application to use specified kinds of medical devices solely for
experimental purposes in humans must:
(a) be made in writing; and
(b) be accompanied by any information about the kinds of devices that is
required by the Secretary; and
(c) be accompanied by the prescribed fee.
(6) The Secretary must:
(a) consider any application under this section; and
(b) assess any information submitted with the application; and
(c) notify the applicant, within 20 working days of making the
decision:
(i) of the decision; and
(ii) in the case of a decision not to grant the approval—of the
reasons for the decision.
(7) The use by a person for experimental purposes in humans of specified
kinds of medical devices that are the subject of an approval granted to someone
else under paragraph (1)(e) is subject to the conditions (if any) specified
in the regulations relating to one or more of the following:
(a) the preconditions on the use of devices of those kinds for those
purposes;
(b) the principles to be followed in the use of devices of those kinds for
those purposes;
(c) the monitoring of the use, and the results of the use, of devices of
those kinds for those purposes;
(d) the circumstances in which the person must cease the use of devices of
those kinds for those purposes.
Note: Breach of the conditions may be an offence: see
subsection 41MN(3).
(1) The Secretary may authorise, in writing, a specified medical
practitioner to supply specified kinds of medical devices for use in the
treatment of humans to a specified class of recipients.
(2) An authority may be given subject to conditions specified in the
authority.
(3) The Secretary may impose conditions (or further conditions) on a
person’s authority by giving the person written notice of the
conditions.
(4) An authority may only be given:
(a) to a medical practitioner included in a class of medical practitioners
prescribed by the regulations for the purposes of this paragraph; and
(b) to a medical practitioner who has the approval of an ethics committee
to supply the specified kinds of medical devices or the specified class of such
devices; and
(c) in relation to a class or classes of recipients prescribed by the
regulations for the purposes of this paragraph.
However, the regulations may prescribe exceptional circumstances in which
paragraph (b) does not apply.
(5) The regulations may prescribe circumstances in which medical devices
may be supplied under an authority.
(6) The giving of an authority in respect of kinds of medical devices does
not render the Commonwealth, the Secretary or a delegate of the Secretary liable
to a person for loss, damage or injury of any kind suffered by the person as a
result of, or arising out of, the use of devices of those kinds by that person
or another person.
(7) In this section:
medical practitioner means a person who is registered, in a
State or internal Territory, as a medical practitioner.
The Secretary may seek information or documents relating to:
• the application of conformity assessment procedures;
• compliance with the essential principles;
• compliance with other requirements;
• distribution of, and other matters relating to, medical devices
covered by exemptions under Part 4-7.
Note: There are additional obligations relating to notifying
defects in medical devices: see sections 41MP and 41MQ.
(1) The Secretary may, by written notice given to a person:
(a) who is an applicant for a conformity assessment certificate that would
relate to a kind of medical device; or
(b) who holds a conformity assessment certificate that relates to a kind
of medical device; or
(c) who is an applicant for the inclusion of a kind of medical device in
the Register; or
(d) in relation to whom a kind of medical device is, or was at any time
during the notice period under subsection (2), included in the
Register;
require the person to give to the Secretary information or documents,
relating to devices of that kind, that are relevant to one or more of the
following:
(e) whether the devices comply with the essential principles;
(f) whether the conformity assessment procedures have been applied to the
devices;
(g) whether the devices comply with conditions (if any) imposed on a
conformity assessment certificate issued in respect of the device or the
inclusion of the device in the Register;
(h) whether the devices comply with every requirement (if any) relating to
advertising applicable under the regulations;
(i) if the kind of medical device is included in the Register in relation
to the person—whether medical devices of that kind are being:
(i) supplied in Australia; or
(ii) imported into Australia; or
(iii) exported from Australia;
(j) any other matter prescribed by the regulations for the purposes of
this paragraph.
(2) For the purposes of paragraph (1)(d), the notice period is the
period:
(a) of the length specified in the regulations; and
(b) ending on the day before the Secretary gives the notice under
subsection (1).
(1) The person must give the information or documents to the
Secretary:
(a) within such reasonable time, being not less than 10 working days from
the day on which the notice is given, as is specified in the notice;
and
(b) in such form as is specified in the notice.
(2) The form may require or permit information to be given in accordance
with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
(3) A person is guilty of an offence if the person:
(a) is a person in relation to whom a notice is given under
section 41JA; and
(b) fails to comply with the notice.
Maximum penalty: 30 penalty units.
Note: Failure to comply with the notice might also lead to
suspension or revocation of a conformity assessment certificate (see
Divisions 3 and 4 of Part 4-4) or suspension or cancellation of the
entry of a kind of medical device in the Register (see
Part 4-6).
(4) A person is guilty of an offence if:
(a) the person is a person in relation to whom a notice is given under
section 41JA; and
(b) the person gives information in purported compliance with the notice;
and
(c) the information is false or misleading in a material
particular.
Maximum penalty: 60 penalty units.
(1) A person is not excused from giving information or a document under
section 41JB on the ground that to do so would tend to incriminate the
person or expose the person to a penalty.
(2) However, in the case of an individual:
(a) the information given; or
(b) the giving of the document; or
(c) any information, document or thing obtained as a direct or indirect
consequence of giving the information or document;
is not admissible in evidence in criminal proceedings against the
individual, except proceedings under, or arising out of, subsection
41JB(4).
(1) The Secretary may give the sponsor of kinds of medical devices
exempted under subsection 41HA(1) from Division 3 of Part 4-11, a
written notice requiring the sponsor to give to the Secretary specified
information or documents relating to one or more of the following:
(a) the supply of devices of those kinds;
(b) the handling of devices of those kinds;
(c) the monitoring of the supply of devices of those kinds;
(d) the results of the supply of devices of those kinds;
(e) any other matter prescribed by the regulations for the purposes of
this paragraph in relation to devices of those kinds.
(2) If a medical device is exempt under subsection 41HA(1) because a
medical practitioner has signed a statement in accordance with regulations made
for the purposes of this section, the Secretary may give the medical
practitioner a written notice requiring the medical practitioner to give to the
Secretary specified information or documents relating to one or more of the
following:
(a) the condition of the person to whom the medical device is to be given
or is given;
(b) the supply of the device;
(c) the handling of the device;
(d) the monitoring of the supply of the device;
(e) the results of the supply of the device;
(f) any other matter prescribed by the regulations for the purposes of
this paragraph in relation to medical devices of that kind.
(3) A notice under this section must specify a reasonable period within
which the person must comply. The period must be at least 10 working days
starting on the day on which the notice is given.
Approval under subsection 41HB(1)
(1) The Secretary may give to a person granted an approval under
subsection 41HB(1) (special and experimental uses), in relation to specified
kinds of medical devices, a written notice requiring the person to give to the
Secretary specified information or documents relating to one or more of the
following:
(a) the supply of devices of those kinds;
(b) the handling of devices of those kinds;
(c) the monitoring of the supply of devices of those kinds;
(d) the results of the supply of devices of those kinds;
(e) any other matter prescribed by the regulations for the purposes of
this paragraph in relation to devices of those kinds.
Approval under subsection 41HB(1)—use by another
person
(2) The Secretary may give to a person using specified kinds of medical
devices, that are the subject of an approval granted to someone else under
paragraph 41HB(1)(e) (use solely for experimental purposes in humans), a written
notice requiring the person to give to the Secretary specified information or
documents relating to either of both of the following:
(a) the use of devices of those kinds;
(b) any other matter prescribed by the regulations for the purposes of
this paragraph in relation to devices of those kinds.
Compliance period
(3) A notice under this section must specify a reasonable period within
which the person to whom the notice is given must comply. The period must be at
least 10 working days starting on the day on which the notice is
given.
(1) The Secretary may give to a person who is granted an authority under
section 41HC (exemptions for medical practitioners), in relation to
specified kinds of medical devices, a written notice requiring the person to
give to the Secretary specified information or documents relating to one or more
of the following:
(a) the supply of devices of those kinds;
(b) the handling of devices of those kinds;
(c) the monitoring of the supply of devices of those kinds;
(d) the results of the supply of devices of those kinds;
(e) any other matter prescribed by the regulations for the purposes of
this paragraph in relation to devices of those kinds.
(2) The notice must specify a reasonable period within which the person to
whom the notice is given must comply. The period must be at least 10 working
days starting on the day on which the notice is given.
When information or documents must be given etc.
(1) A person to whom a notice is given under section 41JD, 41JE or
41JF must give to the Secretary, within the period specified in the
notice:
(a) the information specified in the notice; and
(b) the documents specified in the notice in the form (if any) specified
in the notice.
Way in which information given
(2) The notice may require information to be given in accordance with
specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
Offence
(3) A person is guilty of an offence if the person fails to comply with
subsection (1).
Note: The privilege against self incrimination is not a
reasonable excuse for the purposes of this subsection. However,
section 41JJ limits the use in prosecutions of information etc. obtained
under sections 41JD, 41JE and 41JF.
(4) An offence against subsection (3) is punishable on conviction by
a fine of not more than 30 penalty units.
A person to whom a notice is given under section 41JD, 41JE or 41JF
is guilty of an offence if:
(a) the person gives information to the Secretary; and
(b) the person knows that the information:
(i) is false or misleading; or
(ii) omits any matter or thing without which the information is
misleading; and
(c) the information is given in compliance or purported compliance with
subsection 41JG(1).
Maximum penalty: 60 penalty units.
(1) A person is guilty of an offence if:
(a) the person produces a document to the Secretary; and
(b) the person knows that the document is false or misleading;
and
(c) the document is produced in compliance or purported compliance with
subsection 41JG(1).
Maximum penalty: 60 penalty units.
(2) Subsection (1) does not apply to a person who produces a document
if the document is accompanied by a written statement signed by the person or,
in the case of a body corporate, by a competent officer of the body
corporate:
(a) stating that the document is, to the knowledge of the first-mentioned
person, false or misleading in a material particular; and
(b) setting out, or referring to, the material particular in which the
document is, to the knowledge of the first-mentioned person, false or
misleading.
Note: A defendant bears an evidential burden in relation to
the matter in subsection (2) (see subsection 13.3(3) of the Criminal
Code).
(1) A person is not excused from giving information or a document under
section 41JG on the ground that to do so would tend to incriminate the
person or expose the person to a penalty.
(2) However, in the case of an individual:
(a) the information given; or
(b) the giving of the document; or
(c) any information, document or thing obtained as a direct or indirect
consequence of giving the information or document;
is not admissible in evidence in criminal proceedings against the
individual, except proceedings under, or arising out of, section 41JH or
41JI.
The Secretary can require action to recover medical devices, or to inform
the public about medical devices, that do not comply with requirements or cannot
lawfully be supplied.
(1) The Secretary may, in writing, impose requirements, relating to a kind
of medical device, on a person if:
(a) any of the circumstances referred to in the second column of an item
in the following table occur in relation to the kind of device; and
(b) the person is referred to in the third column of that item of the
table.
|
Circumstances in which requirements may be imposed |
||
|---|---|---|
|
Item |
Circumstance relating to a kind of medical device |
Person subject to requirements |
|
1. |
It is supplied while it is included in the Register, but medical devices of
that kind do not comply with the essential principles |
The person in relation to whom it is included in the Register |
|
2. |
It is supplied while it is included in the Register, but the conformity
assessment procedures have not been applied to medical devices of that
kind |
The person in relation to whom it is included in the Register |
|
3. |
It is supplied while: but medical devices of that kind do not comply with the essential
principles |
The person supplying the kind of medical device |
|
4. |
It is supplied while: but the conformity assessment procedures have not been applied to medical
devices of that kind |
The person supplying the kind of medical device |
|
5. |
It is supplied while: |
The person supplying the kind of medical device |
|
6. |
It has been suspended from the Register |
The person in relation to whom it was included in the Register |
|
7. |
Its entry has been cancelled from the Register |
The person in relation to whom it was included in the Register |
(2) The requirements may be one or both of the following:
(a) to take specified steps, in the specified manner and within such
reasonable period as is specified, to recover medical devices of that kind that
have been distributed;
(b) to inform the public or a specified class of persons, in the specified
manner and within such reasonable period as is specified, to the effect that the
circumstances referred to in paragraph (1)(a) have occurred in relation to
medical devices of that kind.
(3) If the circumstances referred to in paragraph (1)(a) apply only
to some medical devices of that kind, the Secretary may limit the imposition of
the requirements to the medical devices of that kind to which those
circumstances apply.
(4) A requirement to recover medical devices under this section does not
apply to a medical device that cannot be recovered because it has been
administered to, or applied in the treatment of, a person.
The Secretary must cause to be published in the Gazette, as soon
as practicable after imposing a requirement under section 41KA, a notice
setting out particulars of the requirement.
A person is guilty of an offence if:
(a) the person does an act, or omits to do an act; and
(b) the act or omission constitutes a contravention of a requirement
imposed on the person under section 41KA.
Maximum penalty: 60 penalty units.
Imposition of a requirement under section 41KA does not affect the
Secretary’s powers to:
(a) suspend the entry of a kind of medical device, or some medical devices
of a particular kind, from the Register under Part 4-6; or
(b) cancel the entry of a kind of medical device, or some medical devices
of a particular kind, in the Register under Part 4-6.
Conformity assessment fees must be paid for consideration of applications
for conformity assessment certificates. Application audit assessment fees must
be paid for auditing applications that are required to be selected for auditing
under paragraph 41FH(1)(a).
(1) A conformity assessment fee specified in or determined in accordance
with the regulations is payable by a person in respect of consideration of an
application for a conformity assessment certificate under
Part 4-4.
(2) The regulations may prescribe different levels of conformity
assessment fees in relation to any one or more of the following:
(a) different kinds of manufacturers;
(b) different kinds of medical devices;
(c) different parts of the conformity assessment procedures that are
considered in relation to an application for a conformity assessment certificate
under Part 4-4.
(3) An application audit assessment fee specified in or determined in
accordance with the regulations is payable by a person in respect of the
auditing of an application for inclusion of a kind of medical device in the
Register under Part 4-5, if paragraph 41FH(1)(a) required the Secretary to
select the application for audit.
(4) The regulations may prescribe different levels of application audit
assessment fees in relation to any one or more of the following:
(a) different kinds of manufacturers;
(b) different kinds of medical devices;
(c) different levels of assessment of kinds of medical devices.
(5) The application audit assessment fee payable because of
subsection (3) is payable only in respect of considering the matters set
out in subsection 41FI(1).
Subject to sections 41LC and 41LE, an assessment fee payable by an
applicant is due and payable on the day, and in the manner, specified in the
regulations.
(1) The regulations may provide for the payment of an assessment fee to be
made by such instalments and at such times as are ascertained in accordance with
the regulations, and the assessment fee is due and payable
accordingly.
(2) Regulations made for the purposes of subsection (1) may provide
that a person is not allowed to pay an assessment fee by instalments if any part
of an instalment of:
(a) that or any other assessment fee payable by the person; or
(b) any evaluation fee under section 24 payable by the
person;
was unpaid immediately after the time when it became due for
payment.
(3) Subsection (2) does not limit the generality of
subsection (1).
An assessment fee may be recovered by the Commonwealth as a debt due to
the Commonwealth.
(1) Nothing in section 41LA, 41LB or 41LC requires the applicant to
pay more than 3/4 of the
conformity assessment fee before the making of the decision if:
(a) the application is for the issuing of a conformity assessment
certificate under Part 4-4; and
(b) consideration of the application will involve an examination of the
design of medical devices; and
(c) a period is prescribed under paragraph 63(2)(dc) for making a decision
on the application.
(2) If the decision is not made within that period, the conformity
assessment fee is 3/4 of
the fee that, apart from this subsection, would have been the conformity
assessment fee.
(3) If:
(a) the decision is made within that period; and
(b) part of the conformity assessment fee under section 41LA is,
because of subsection (1) of this section, unpaid when the decision is
made;
that part becomes due and payable on the making of the decision.
(4) For the purposes of this section, a decision is taken to be made on
the application when the applicant is notified under subsection 41EE(1) of the
Secretary’s decision on the application.
This Part contains offences that are aimed at ensuring that:
• the essential principles are complied with (see
Division 1);
• the conformity assessment procedures have been applied to kinds of
medical devices (see Division 2);
• administrative processes put in place by Parts 4-4 to 4-9 are
followed (see Divisions 3 and 4).
Note: There are also some offences in the earlier Parts of
this Chapter. They generally relate to matters ancillary to administrative
processes in those Parts (e.g. false or misleading statements in
applications).
(1) A person is guilty of an offence if:
(a) the person imports a medical device into Australia; and
(b) the medical device does not comply with the essential principles
relating to matters other than the labelling of the device; and
(c) the Secretary has not consented to the importation.
Maximum penalty: 240 penalty units.
(2) A person is guilty of an offence if:
(a) the person supplies a medical device for use in Australia;
and
(b) the medical device does not comply with the essential principles;
and
(c) the Secretary has not consented to the supply.
Maximum penalty: 240 penalty units.
(3) A person is guilty of an offence if:
(a) the person exports a medical device from Australia; and
(b) the medical device does not comply with the essential principles;
and
(c) the Secretary has not consented to the exportation.
Maximum penalty: 240 penalty units.
(4) Paragraph (3)(b) does not apply to the extent that the essential
principles in question relate to labelling medical devices for supply in
Australia.
Note: A defendant bears an evidential burden in relation to
the matters in this subsection (see subsection 13.3(3) of the Criminal
Code).
(5) The Secretary must not give consent relating to an exportation unless
satisfied that there are exceptional circumstances that justify giving the
consent.
(1) Section 41MA does not apply if:
(a) the medical device complies with one or more medical device standards
that apply to it; and
(b) the medical device fails to comply with the essential principles only
in respect of a part or parts of the essential principles to which that medical
device standard, or one or more of those medical device standards,
relate.
Note: Medical device standards are determined under
Division 2 of Part 4-2.
(2) For the purposes of this section, a medical device standard relates to
a part or parts of the essential principles only if the standard specifies that
part or parts.
Note: A defendant bears an evidential burden in relation to
the matters in this section (see subsection 13.3(3) of the Criminal
Code).
(1) The consent of the Secretary under section 41MA may be
given:
(a) unconditionally or subject to conditions; or
(b) in respect of particular medical devices or kinds of medical
devices.
(2) A person is guilty of an offence if:
(a) the person does an act, or omits to do an act; and
(b) the act or omission constitutes a breach of a condition of such a
consent.
Maximum penalty: 120 penalty units.
If:
(a) the importation or exportation of a medical device is prohibited under
subsection 41MA(1) or (3); and
(b) the Secretary notifies the Chief Executive Officer of Customs in
writing that the Secretary wishes the Customs Act 1901 to apply to that
importation or exportation;
the Customs Act 1901 has effect as if the device included in that
importation or exportation were goods described as forfeited to the Crown under
section 229 of that Act because they were:
(c) prohibited imports within the meaning of that Act; or
(d) prohibited exports within the meaning of that Act;
as the case requires.
(1) A person is guilty of an offence if:
(a) the person supplies in Australia a medical device that the person has
manufactured; and
(b) the conformity assessment procedures have not been applied to the
device.
Maximum penalty: 240 penalty units.
(2) A person is guilty of an offence if:
(a) the person exports from Australia a medical device that the person has
manufactured; and
(b) the conformity assessment procedures have not been applied to the
device.
Maximum penalty: 240 penalty units.
(1) A person is guilty of an offence if:
(a) the person supplies a medical device in Australia; and
(b) the conformity assessment procedures have not been applied to the
device.
Maximum penalty: 240 penalty units.
(2) A person is guilty of an offence if:
(a) the person exports a medical device from Australia; and
(b) the conformity assessment procedures have not been applied to the
device.
Maximum penalty: 240 penalty units.
(3) This section does not apply if the defendant was not the sponsor of
the device at the time of the supply or export, as the case may be.
Note: A defendant bears an evidential burden in relation to
the matters in subsection (3) (see subsection 13.3(3) of the Criminal
Code).
(1) Sections 41ME and 41MF do not apply to the extent that:
(a) the quality management systems applied to the medical device comply
with one or more conformity assessment standards that apply to them;
and
(b) the conformity assessment procedures have not been applied to the
device only in respect of a part or parts of the conformity assessment
procedures to which one or more of those conformity assessment standards
relate.
Note: Conformity assessment standards are determined under
Division 2 of Part 4-3.
(2) For the purposes of this section, a conformity assessment standard
relates to a part or parts of the conformity assessment procedures only if the
standard specifies that part or parts.
Note: A defendant bears an evidential burden in relation to
the matters in this section (see subsection 13.3(3) of the Criminal
Code).
A person is guilty of an offence if:
(a) the person makes a statement in or in connection with a declaration,
relating to the application of conformity assessment procedures to a medical
device that the person has manufactured; and
(b) the statement is false or misleading in a material
particular.
Maximum penalty: 400 penalty units.
(1) A person is guilty of an offence if:
(a) the person:
(i) imports a medical device into Australia; or
(ii) exports a medical device from Australia; or
(iii) supplies a medical device in Australia; or
(iv) manufactures a medical device in Australia; and
(b) none of the following subparagraphs applies in relation to the
device:
(i) the device is of a kind included in the Register in relation to the
person;
(ii) the device is an exempt device;
(iii) the device is the subject of an approval under section 41HB or
an authority under section 41HC.
Maximum penalty: 240 penalty units.
(2) Strict liability applies to paragraph (1)(b).
Note: For strict liability, see
section 6.1 of the Criminal Code.
(3) Subsection (1) does not apply if the defendant proves that the
defendant was not the sponsor of the device at the time of the importation,
export, supply, or manufacture, as the case may be.
Note: A defendant bears a legal burden in relation to the
matters in subsection (3) (see section 13.4 of the Criminal
Code).
If:
(a) the importation or exportation of a medical device is prohibited under
subsection 41MI(1); and
(b) the Secretary notifies the Chief Executive Officer of Customs in
writing that the Secretary wishes the Customs Act 1901 to apply to that
importation or exportation;
the Customs Act 1901 has effect as if the device included in that
importation or exportation were goods described as forfeited to the Crown under
section 229 of that Act because they were:
(c) prohibited imports within the meaning of that Act; or
(d) prohibited exports within the meaning of that Act;
as the case requires.
A person is guilty of an offence if:
(a) the person supplies a medical device in Australia; and
(b) none of the following subparagraphs applies in relation to the
device:
(i) the device is of a kind included in the Register;
(ii) the device is an exempt device;
(iii) the device is the subject of an approval under section 41HB or
an authority under section 41HC; and
(c) the person to whom the device is supplied is not the ultimate consumer
of the device.
Maximum penalty: 120 penalty units.
(1) A person is guilty of an offence if:
(a) the person makes a representation of a kind referred to in
subsection (2); and
(b) the representation is false or misleading.
Maximum penalty: 60 penalty units.
(2) Subsection (1) applies to these representations:
(a) representations that medical devices are of a kind included in the
Register;
(b) representations that medical devices are exempt devices;
(c) representations that medical devices are the subject of an approval
under section 41HB or an authority under section 41HC.
(3) A person is guilty of an offence if:
(a) a kind of medical device is included in the Register in respect of a
person; and
(b) the person, by any means, advertises the goods as being for a purpose
other than that accepted in relation to that inclusion.
Maximum penalty: 60 penalty units.
A person is guilty of an offence if:
(a) the person claims, by any means, that the person or another person can
arrange the supply of medical devices; and
(b) the devices are not:
(i) medical devices of a kind included in the Register; or
(ii) exempt devices.
Maximum penalty: 60 penalty units.
(1) A person is guilty of an offence if:
(a) a kind of medical device is included in the Register in relation to
the person; and
(b) the person does an act, or omits to do an act; and
(c) the act or omission constitutes a breach of a condition of the
inclusion of the kind of device in the Register.
Maximum penalty: 60 penalty units.
(2) A person is guilty of an offence if:
(a) a conformity assessment certificate is issued in respect of a person;
and
(b) the person does an act, or omits to do an act; and
(c) the act or omission constitutes a breach of a condition of the
conformity assessment certificate.
Maximum penalty: 60 penalty units.
(3) A person is guilty of an offence if:
(a) the person does an act, or omits to do an act; and
(b) the act or omission constitutes a breach of:
(i) a condition of an exemption applicable under regulations made for the
purposes of section 41HA; or
(ii) a condition of an approval under section 41HB; or
(iii) a condition applicable under regulations made for the purposes of
subsection 41HB(7).
Maximum penalty: 60 penalty units.
(1) A person is guilty of an offence if he or she:
(a) has been granted an authority under section 41HC relating to a
specified kind of medical device; and
(b) supplies a medical device of that kind:
(i) other than in accordance with the authority; or
(ii) other than in accordance with any conditions to which the
authority is subject; or
(iii) other than in accordance with any regulations made for the
purpose of subsection 41HC(5).
Maximum penalty: 60 penalty units.
(2) A person is guilty of an offence if:
(a) he or she has been granted an approval under section 41HB
relating to a specified medical device or specified kind of medical device;
and
(b) he or she uses a medical device of that kind:
(i) in the treatment of another person; or
(ii) solely for experimental purposes in humans;
in a way that is not in accordance with the approval.
Maximum penalty: 60 penalty units.
(1) A person is guilty of an offence if:
(a) the person is a person in relation to whom a kind of medical device is
included in the Register; and
(b) the person knows that particular information is information of a kind
mentioned in subsection (2); and
(c) the person fails to give that information to the Secretary within the
period specified in the regulations (whether or not the person has already given
to the Secretary other information relating to the same matter).
Maximum penalty: 400 penalty units.
(2) The information with which subsection (1) is concerned is
information of the following kinds:
(a) information relating to:
(i) any malfunction or deterioration in the characteristics or performance
of a kind of device; or
(ii) any inadequacy in the design, manufacture, labelling, instructions
for use or advertising materials of a kind of device; or
(iii) any use in accordance with, or contrary to, the use intended by the
manufacturer of the kind of device;
that might lead, or might have led, to the death of a patient or a user
of the device, or to a serious deterioration in his or her state of
health;
(b) information relating to any technical or medical reason for a
malfunction or deterioration of a kind referred to in subparagraph (a)(i)
that has led the manufacturer to take steps to recover devices of that kind that
have been distributed;
(c) information that indicates that a device of that kind does not comply
with the essential principles;
(d) information that indicates that a certificate (other than one issued
under this Act) used for the purpose of an application under subsection
41FC(1) to signify:
(i) compliance with the essential principles; or
(ii) the application of relevant conformity assessment procedures to a
particular device;
has been restricted, suspended, revoked or is no longer in
effect.
(1) If an application for inclusion of a kind of medical device in the
Register is withdrawn or lapses, the Secretary may give the applicant written
notice requiring the applicant:
(a) to inform the Secretary in writing whether the applicant is aware of
any information of a kind mentioned in subsection 41MP(2) relating to the kind
of device; and
(b) if the applicant is aware of such information, to give the information
to the Secretary in writing.
(2) Notice under subsection (1) may only be given within 10 working
days after an application is withdrawn or lapses.
(3) A person is guilty of an offence if the person fails to comply with
the requirements of a notice under subsection (1) within 20 working days
after the notice is given to the person.
Maximum penalty: 400 penalty units.
(4) A person is guilty of an offence if:
(a) the person gives information in purported compliance with a notice
under this section; and
(b) the information is false or misleading in a material
particular.
Maximum penalty: 400 penalty units.
60 Part 4A (heading)
Repeal the heading, substitute:
61 Part 4B (heading)
Repeal the heading, substitute:
62 Part 4C (heading)
Repeal the heading, substitute:
63 At the end of subsection
42V(7)
Add “or Division 1 or 2 of Part 4-6”.
64 Part 5 (heading)
Repeal the heading, substitute:
65 Subsection 43(1)
Omit “or annual listing charge”, substitute “, annual
listing charge or annual charge for inclusion in the Register”.
66 Subsection 43(1)
Omit “or listed”, substitute “, listed or included in the
Register”.
67 Subsection 44(1)
Omit “or annual listing charge”, substitute “, annual
listing charge or annual charge for inclusion in the Register”.
68 Subparagraph 44(1)(b)(i)
Omit “or listing”, substitute “, listing or inclusion in
the Register”.
69 Subparagraph
44(1)(b)(ii)
Omit “or listed”, substitute “, listed or included in the
Register”.
70 Subsection 44(3)
After “annual listing charge”, insert “, an annual charge
for inclusion in the Register”.
71 Paragraph 45(4)(b)
After “annual listing charge”, insert “, annual charge
for inclusion in the Register”.
72 Part 5A (heading)
Repeal the heading, substitute:
73 After subparagraph
46A(4)(a)(ii)
Insert:
(iia) who has been granted an approval or authority under
section 41HB or 41HC; or
74 Subparagraph
46A(4)(a)(iii)
Omit “or listed”, substitute “, listed or included in the
Register”.
75 Paragraph 46A(4)(b)
Omit “or listed”, substitute “, listed or included in the
Register”.
76 Paragraph 46A(4)(c)
Omit “Part 4 for”, substitute “Part 3-3 for, or
a conformity assessment certificate issued under Part 4-4, in relation
to”.
77 Part 5B (heading)
Repeal the heading, substitute:
78 Part 5C (heading)
Repeal the heading, substitute:
79 Part 6 (heading)
Repeal the heading, substitute:
80 Section 53
Repeal the section, substitute:
Where a person withdraws an application for:
(a) registration; or
(b) listing; or
(c) a conformity assessment certificate; or
(d) inclusion of a kind of medical device in the Register; or
(e) a licence;
the Department may retain the application and any material submitted in
connection with the application.
81 Subsection 54(1)
Omit “or 29B”, substitute “, 29B, 41FE, 41MP or
41MQ”.
82 Section 56
After “all courts”, insert “(except in proceedings under
Chapter 4)”.
83 After paragraph
56A(1)(a)
Insert:
(aa) particular medical devices were not exempt devices;
84 After paragraph
56A(1)(b)
Insert:
(ba) there was no approval or authority in effect under section 41HB
or 41HC granted to a particular person in relation to particular medical
devices;
85 After paragraph
56A(1)(e)
Insert:
(ea) particular medical devices were or were not medical devices of a kind
included in the Register; or
(eb) particular medical devices were suspended from the Register;
or
86 Paragraph 56A(1)(g)
Omit “or listing”, substitute “, listing or inclusion in
the Register”.
87 Paragraph 56A(1)(i)
Omit “Part 4”, substitute
“Part 3-3”.
88 At the end of subsection
56A(1)
Add:
; or (m) a conformity assessment certificate has been issued relating to a
particular kind of medical device; or
(n) a conformity assessment certificate was subject to conditions
including those specified in the certificate under this section; or
(o) a conformity assessment certificate was suspended.
89 Subsection 56A(2)
Omit “paragraphs (1)(a) to (l)”, substitute
“paragraphs (1)(a) to (o)”.
90 Subsection 56A(4)
After “section 14”, insert “or
41MA”.
91 Subsections 57(2) and
(3)
After “paragraph 19(1)(a)”, insert “or
41HB(1)(d)”.
92 Paragraph 57(5)(b)
After “paragraph 19(1)(a)”, insert “or
41HB(1)(d)”.
93 Subsections 57(6) and
(7)
After “subsection 19(5)”, insert “or
41HC(1)”.
94 Subsection 60(1) (paragraph (a) of the
definition of initial decision)
After “subsection 7(1)”, insert “or
41BD(3)”.
95 Subsection 60(1) (after paragraph (a) of
the definition of initial decision)
Insert:
(ab) under section 9C or 9D; or
96 Subsection 60(1) (paragraph (c) of the
definition of initial decision)
Repeal the paragraph, substitute:
(c) under Part 3-2 (registration and listing of therapeutic goods);
or
(d) under Part 3-3 (manufacturing of therapeutic goods); or
(e) under Part 4-4 (conformity assessment certificates); or
(f) under Part 4-5 (including medical devices in the Register), other
than:
(i) a decision under section 41FH (selecting applications for
auditing); or
(ii) a decision about which aspects of the matters referred to in
paragraphs 41FI(1)(a) and (b) to consider in auditing an application under
Subdivision C of Division 1 of Part 4-5; or
(g) under Part 4-6 (suspension and cancellation from the Register);
or
(h) under Part 4-7 (exempting medical devices from inclusion in the
Register); or
(i) under Part 4-8 (obtaining information); or
(j) under Part 4-9 (public notification and recovery of medical
devices); or
(k) refusing to grant, or imposing conditions on a grant of, a consent for
the purposes of section 41MA (non-compliance with essential
principles).
97 After subsection 60(1)
Insert:
(1A) For the avoidance of doubt, the following are not initial decisions
for the purposes of this section or section 60A:
(a) a proposal to suspend a conformity assessment certificate under
section 41EM;
(b) a proposal to revoke a conformity assessment certificate under
section 41ET;
(c) a proposal to suspend a kind of medical device from the Register under
section 41GA;
(d) a proposal to cancel the entry of a kind of medical device on the
Register under section 41GN.
98 Subsection 60A(1)
After “section 25”, insert “or
41EC”.
99 Before paragraph
60A(6)(a)
Insert:
(aa) the matter relates to a decision under section 25; and
100 After subsection 60A(6)
Insert:
(6A) If:
(a) the matter relates to a decision under section 41EC;
and
(b) the Minister or the Tribunal remits the matter; and
(c) the appellant has paid, as a further conformity assessment fee, the
conformity assessment fee that the appellant would have to pay under
section 41LA on making a new application for a conformity assessment
certificate;
the authorised delegate must make a decision under section 41EC,
taking into account the new information, as if a fresh application for a
conformity assessment certificate had been made.
101 Subsection 60A(7)
Omit “Part 3”, substitute “Part 3-2 or
4-4”.
102 After subparagraph
61(2)(a)(iii)
Insert:
or (iv) the issue of, imposition of conditions on, or revocation of,
conformity assessment certificates;
103 After paragraph
61(3)(e)
Insert:
or (f) the issue of, imposition of conditions on, or revocation of,
conformity assessment certificates;
104 Subsection 61(3A)
Omit “or 31B”, substitute “, 31B, 41JD, 41JE or
41JF”.
105 After paragraph
61(4)(b)
Insert:
(ba) decisions on the inclusion of kinds of medical devices in the
Register, or the cancellation of the inclusion of kinds of medical devices in
the Register; or
106 After paragraph
61(4)(e)
Insert:
or (f) the issue of, imposition of conditions on, or revocation of,
conformity assessment certificates;
107 Paragraphs 61(4A)(d) and
(e)
Omit “Part 4C”, substitute
“Part 5-3”.
108 Paragraph 61(6)(b)
Omit “registration or listing”, substitute “registration,
listing or inclusion in the Register”.
109 After paragraph
63(2)(da)
Insert:
; and (db) provide for the periods within which decisions under
section 41EP to revoke suspensions of conformity assessment certificates
are to be made, in cases where applications for revocation have been made under
paragraph 41EP(2)(a); and
(dc) provide for the periods within which decisions on applications for
the issuing of conformity assessment certificates under Part 4-4 are to be
made if considering the applications involves examining the design of medical
devices; and
(dd) provide for the periods within which decisions under
section 41GD to revoke suspensions of entries on the Register are to be
made, in cases where applications for revocation have been made under paragraph
41GD(2)(a); and
110 Paragraph 63(2)(f)
Omit “or listing”, substitute “, listing or inclusion in
the Register”.
111 Subparagraph
63(3)(a)(ii)
Omit “Part 4”, substitute
“Part 3-3”.
112 Part 7 (heading)
Repeal the heading, substitute:
113 Section 69
Omit “Part 2” (last occurring), substitute
“Part 3-1”.
1 Subsection 3(1) (definition of gazetted
therapeutic devices group)
Repeal the definition.
2 Subsection 3(1) (paragraph (b) of the
definition of grouped therapeutic goods)
Repeal the paragraph.
3 Subsection 3(1) (definition of listable
devices)
Repeal the definition.
4 Subsection 3(1) (definition of
medicine)
Repeal the definition, substitute:
medicine means therapeutic goods that are represented to
achieve, or are likely to achieve, their principal intended action by
pharmacological, chemical, immunological or metabolic means in or on the body of
a human or animal.
5 Subsection 3(1) (definition of therapeutic
device)
Repeal the definition.
6 Paragraph 7B(2)(b)
Omit “or therapeutic devices”.
7 Chapter 3 (note following the
heading)
Repeal the note.
8 Section 10A
Omit “unless Part 3-2 applies to the device”.
9 Section 15A
Repeal the section, substitute:
This Part does not apply to a medical device.
10 Subsection 16(2)
Omit “or therapeutic devices”.
11 Subsection 16(3)
Repeal the subsection.
12 Paragraphs 20(2)(a) and
(b)
Repeal the paragraphs, substitute:
(a) the registration number or listing number of the goods is set out on
the label of the goods in the prescribed manner; or
(b) in the case of an importation, that number is so set out, or is to be
so set out before the goods are supplied in Australia.
13 Section 21
Omit “(other than listable devices)”.
14 Subparagraph 25(2)(a)(i)
Omit “if the goods are not therapeutic devices”, substitute
“if the goods are medicines”.
15 Paragraph 25A(2)(a)
Repeal the paragraph, substitute:
(a) the information was given to the Secretary in relation to an
application to register therapeutic goods (the new goods)
consisting of, or containing, an active component; and
16 Section 25B
Repeal the section.
17 Subsection 26(1)
Omit “, subject to section 26AA,”.
18 Paragraph 26(1)(g)
Omit “not being therapeutic devices other than devices”,
substitute “being medicines or other therapeutic goods”.
19 Subparagraph 26(2)(a)(i)
Omit “if the goods are not therapeutic devices”, substitute
“if the goods are medicines”.
20 Section 26AA
Repeal the section.
21 Chapter 4 (note following the
heading)
Repeal the note.
22 Section 41BJ
Repeal the section.
23 Subsection 60(1) (paragraph (a) of the
definition of initial decision)
Omit “under the definition of therapeutic devices in
subsection 3(1) or”.