Commonwealth Numbered Acts Commonwealth Numbered Acts
1 After paragraph 41BB(c)
Insert:
(ca) exempting medical devices from various provisions of this Chapter to deal with emergency situations; and
2 After Part 4‑6
Insert:
Part 4‑6A -- Exempting medical devices to deal with emergencies
The Minister may exempt certain medical devices from various provisions of this Chapter so that the devices may be stockpiled to deal with possible future emergencies or made available urgently to deal with actual emergencies.
Note 1: There are offences and civil penalty provisions related to the making of exemptions under this Part: see Division 3A of Part 4‑11.
Note 2: Some of the other provisions of this Act about medical devices exempt under this Part are:
(a) section 41JCA (providing information to the Secretary); and
(b) section 41KA (public notification and recovery of medical devices); and
(c) section 46A (search of premises).
41GS Minister may make exemptions
(1) The Minister may, by writing, exempt specified kinds of medical devices from the operation of the following:
(a) Division 1 of Part 4‑2 (essential principles);
(b) Division 1 of Part 4‑3 (conformity assessment procedures);
(c) Part 4‑4 (conformity assessment certificates);
(d) Part 4‑5 (including medical devices in the Register).
(2) The Minister may make an exemption under subsection (1) only if the Minister is satisfied that, in the national interest, the exemption should be made so that:
(a) the devices may be stockpiled as quickly as possible in order to create a preparedness to deal with a potential threat to public health that may be caused by a possible future emergency; or
(b) the devices can be made available urgently in Australia in order to deal with an actual threat to public health caused by an emergency that has occurred.
Period of exemption
(3) An exemption under subsection (1) comes into force:
(a) on the day the exemption is made; or
(b) on a later day specified in the exemption.
(4) An exemption under subsection (1) remains in force for the period specified in the exemption, unless revoked earlier.
Note: Section 41GU deals with variation and revocation of the exemption.
Effect of inclusion of kind of medical device in the Register
(5) An exemption under subsection (1) ceases to have effect in relation to a particular kind of medical device when that kind of medical device becomes included in the Register under Part 4‑5.
Exemption not a legislative instrument
(6) An exemption under subsection (1) is not a legislative instrument.
Disregard section 41BE
(7) For the purposes of this Act, disregard section 41BE in working out the kinds of medical devices covered by an exemption under subsection (1) of this section.
An exemption under section 41GS is subject to conditions specified in the exemption about any of the following:
(a) the quantity of medical devices that are exempt;
(b) the source of those medical devices;
(c) the persons or class of persons who may import, manufacture, supply or export those medical devices;
(d) the supply of those medical devices (including the persons or class of persons to whom medical devices may be supplied for use and the circumstances under which a stockpile of medical devices may be supplied for use);
(e) the storage and security of those medical devices;
(f) the keeping and disclosure of, and access to, records about those medical devices;
(g) the disposal of those medical devices;
(h) the manner in which any of those medical devices are to be dealt with if a condition of the exemption is breached;
(i) any other matters that the Minister thinks appropriate.
Whether or not medical devices are exempt under section 41GS is not affected by whether or not there is a breach of a condition under this section in relation to those medical devices.
Note 1: There are offences and civil penalty provisions related to the breach of a condition of an exemption: see Division 3A of Part 4‑11.
Note 2: Section 41GU deals with variation and revocation of the conditions.
41GU Variation or revocation of exemption
Variation of exemption
(1) The Minister may, by writing, vary an exemption made under section 41GS by removin g specified kinds of medical devices from the exemption.
Revocation of exemption
(2) The Minister may, by writing, revoke an exemption made under section 41GS.
Variation or revocation of conditions
(3) The Minister may, by writing:
(a) vary the conditions of an exemption made under section 41GS (including by imposing new conditions); or
(b) revoke the conditions of an exemption made under section 41GS.
When variation or revocation takes effect
(4) A variation or revocation under this section takes effect:
(a) if the Minister states in the variation or revocation that the variation or revocation is necessary to prevent imminent risk of death, serious illness or serious injury--on the day the variation or revocation is made; or
(b) in any other case--on a later day specified in the variation or revocation (which must not be earlier than 28 days after the day the variation or revocation is made).
41GV Informing persons of exemption etc.
If the Minister makes an exemption under section 41GS, the Minister must take reasonable steps to give a copy of the following to each person covered by paragraph 41GT(c):
(a) the exemption;
(b) any variation or revocation of the exemption under section 41GU.
Notification
(1) The Secretary must cause a notice setting out particulars of the following:
(a) an exemption made under section 41GS because of paragraph 41GS(2)(b);
(b) a variation or revocation under section 41GU, to the extent that the variation or revocation relates to an exemption made under section 41GS because of paragraph 41GS(2)(b);
to be published in the Gazette within 5 working days after the day on which the exemption, variation or revocation is made. However, the exemption, variation or revocation is not invalid merely because of a failure to comply with this subsection.
Tabling
(2) The Minister must cause a document setting out particulars of the following:
(a) an exemption made under section 41GS because of paragraph 41GS(2)(b);
(b) a variation or revocation under section 41GU, to the extent that the variation or revocation relates to an exemption made under section 41GS because of paragraph 41GS(2)(b);
to be tabled in each House of the Parliament within 5 sitting days of that House after the day on which the exemption, variation or revocation is made. However, the exemption, variation or revocation is not invalid merely because of a failure to comply with this subsection.
41GX Exclusion of liability of the Commonwealth etc.
An exemption under section 41GS does not render the Commonwealth, the Minister or a delegate of the Minister 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 by that person or another person of a medical device of a kind covered by the exemption.
41GY Disposal of unused medical devices
(1) This section applies to a medical device if:
(a) an exemption under section 41GS in relation to that kind of medical device ceases to have effect otherwise than because that kind of medical device becomes included in the Register under Part 4‑5; and
(b) the medical device has not been used before the exemption so ceases to have effect.
(2) The Secretary may arrange for the disposal of the medical device in accordance with the regulations.
(3) Regulations made for the purposes of subsection (2) may set out the methods by which the medical device is to be stored, supplied, destroyed, exported or otherwise disposed of.
(4) A method set out in the regulations under subsection (3) must not enable or permit any benefit to be conferred on a person (including the Commonwealth) other than the owner of the medical device.
3 Part 4‑7 (heading)
Repeal the heading, substitute:
Part 4‑7 -- Other exemptions from including medical devices in the Register
4 Section 41H
Omit "There are 3", substitute "In addition to Part 4‑6A, there are 3 other".
5 Section 41J
After "exemptions under", insert "Part 4‑6A or".
6 Before section 41JD
Insert:
41JCA Secretary may require information etc. about medical devices exempt under Part 4‑6A
(1) This section applies to a person who is required to comply with a condition of an exemption of a kind of medical device under section 41GS.
(2) The Secretary may, by written notice given to the person, require 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 that kind;
(b) the handling of devices of that kind;
(c) the monitoring of the supply of devices of that kind;
(d) the results of the supply of devices of that kind;
(e) any other matter prescribed by the regulations for the purposes of this paragraph in relation to devices of that kind.
(3) 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.
(4) 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.
7 Paragraph 41JG(a)
After "section", insert "41JCA,".
8 Section 41JG (note)
After "sections", insert "41JCA,".
9 Section 41JH
After "section", insert "41JCA,".
10 Paragraph 41JI(1)(c)
After "section", insert "41JCA,".
11 Subsection 41JJ(1)
After "section", insert "41JCA,".
12 Subsection 41KA(1) (after paragraph (a) of the cell at table item 5, column headed "Circumstance relating to a kind of medical device")
Insert:
|
(aa) it is not covered by an exemption in force under section 41GS; and |
13 Subsection 41KA(1) (after table item 5)
Insert:
|
5A. |
It is supplied while it is covered by an exemption in force under section 41GS, and the Secretary is satisfied that it is not fit to be used for its intended purpose |
The person supplying the kind of medical device |
14 Section 41M
After "Divisions 3", insert ", 3A".
15 After paragraphs 41MA(1)(c) and (2)(c)
Insert:
(ca) the device is not of a kind covered by an exemption in force under section 41GS; and
16 After paragraph 41MA(4)(c)
Insert:
; and (d) the device is not of a kind covered by an exemption in force under section 41GS.
17 After paragraphs 41MA(5)(c) and (6)(c)
Insert:
(ca) the device is not of a kind covered by an exemption in force under section 41GS; and
18 After paragraph 41MA(8)(c)
Insert:
; and (d) the device is not of a kind covered by an exemption in force under section 41GS.
19 After paragraphs 41MA(9)(c) and (10)(c)
Insert:
(ca) the device is not of a kind covered by an exemption in force under section 41GS; and
20 After paragraph 41MA(12)(c)
Insert:
; and (d) the device is not of a kind covered by an exemption in force under section 41GS.
21 After paragraphs 41MAA(1)(c), (2)(c) and (3)(c)
Insert:
; and (d) the device is not of a kind covered by an exemption in force under section 41GS.
22 After paragraphs 41ME(1)(c) and (2)(c)
Insert:
(ca) the device is not of a kind covered by an exemption in force under section 41GS; and
23 After paragraph 41ME(4)(c)
Insert:
; and (d) the device is not of a kind covered by an exemption in force under section 41GS.
24 After paragraphs 41ME(5)(c) and (6)(c)
Insert:
(ca) the device is not of a kind covered by an exemption in force under section 41GS; and
25 After paragraph 41ME(8)(c)
Insert:
; and (d) the device is not of a kind covered by an exemption in force under section 41GS.
26 After paragraphs 41MEA(1)(c) and (2)(c)
Insert:
; and (d) the device is not of a kind covered by an exemption in force under section 41GS.
27 After paragraph 41MF(1)(b)
Insert:
(ba) the device is not of a kind covered by an exemption in force under section 41GS; and
28 After paragraph 41MF(2)(b)
Insert:
; and (c) the device is not of a kind covered by an exemption in force under section 41GS.
29 After paragraph 41MF(3)(b)
Insert:
(ba) the device is not of a kind covered by an exemption in force under section 41GS; and
30 After paragraph 41MF(4)(b)
Insert:
; and (c) the device is not of a kind covered by an exemption in force under section 41GS.
31 After subparagraphs 41MI(1)(b)(i), (2)(b)(i) and (4)(b)(i)
Insert:
(ia) the device is of a kind covered by an exemption in force under section 41GS;
32 Paragraph 41MIB(1)(b)
Omit "paragraphs", substitute "subparagraphs".
33 After subparagraph 41MIB(1)(b)(i)
Insert:
(ia) the device is of a kind covered by an exemption in force under section 41GS;
34 After subparagraph 41MK(b)(i)
Insert:
(ia) the device is of a kind covered by an exemption in force under section 41GS;
35 After Division 3 of Part 4‑11
Insert:
Division 3A -- Offences and civil penalties related to exemptions under Part 4‑6A
41MNB Criminal offences for breaching a condition of an exemption
(1) A person commits an offence if:
(a) the person does an act or omits to do an act in relation to a medical device; and
(b) the device is of a kind covered by an exemption in force under section 41GS; and
(c) the act or omission results in the breach of a condition of the exemption; and
(d) the act or omission is likely to cause a serious risk to public health.
Penalty: Imprisonment for 5 years or 2,000 penalty units, or both.
(2) Strict liability applies to paragraph (1)(b).
Note: For strict liability, see section 6.1 of the Criminal Code .
(3) A person commits an offence if:
(a) the person does an act or omits to do an act in relation to a medical device; and
(b) the device is of a kind covered by an exemption in force under section 41GS; and
(c) the act or omission results in the breach of a condition of the exemption.
Penalty: Imprisonment for 4 years or 240 penalty units, or both.
(4) Strict liability applies to paragraph (3)(b).
Note: For strict liability, see section 6.1 of the Criminal Code .
(5) A person commits an offence if:
(a) the person does an act or omits to do an act in relation to a medical device; and
(b) the device is of a kind covered by an exemption in force under section 41GS; and
(c) the act or omission results in the breach of a condition of the exemption.
Penalty: 60 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code .
41MNC Civil penalty for breaching a condition of an exemption
A person contravenes this section if:
(a) the person does an act or omits to do an act in relation to a medical device; and
(b) the device is of a kind covered by an exemption in force under section 41GS; and
(c) the act or omission results in the breach of a condition of the exemption.
Maximum civil penalty:
(a) for an individual--5,000 penalty units; and
(b) for a body corporate--50,000 penalty units.
41MND Civil penalty for making misrepresentations about medical devices
A person contravenes this section if:
(a) the person makes a representation that medical devices are of a kind covered by an exemption in force under section 41GS; and
(b) the representation is false or misleading.
Maximum civil penalty:
(a) for an individual--5,000 penalty units; and
(b) for a body corporate--50,000 penalty units.
36 After subparagraph 46A(4)(a)(ii)
Insert:
(iiaa) who is required to comply with a condition of an exemption of a kind of medical device under section 41GS; or
37 After paragraph 56A(1)(a)
Insert:
(aaa) there was no exemption in force under section 41GS in relation to a particular kind of medical device; or
38 Subsection 57(1)
Omit "(10)", substitute "(11)".
39 At the end of section 57
Add:
(11) The power of the Minister under subsection 41GS(1) may be delegated only to the Secretary.
40 Subsection 61(3A)
After "31B,", insert "41JCA,".