Commonwealth Numbered Regulations

THERAPEUTIC GOODS LEGISLATION AMENDMENT (2019 MEASURES NO. 1) REGULATIONS 2019 (F2019L01660) - SCHEDULE 3

Part 1 -- Definitions

Therapeutic Goods (Medical Devices) Regulations 2002

1  At the end of Part 1

Add:

1.8   Classes of persons that are not manufacturers of a medical device

                   For the purposes of subsection 41BG(4) of the Act, a class of persons is health professionals, or suitably qualified persons within a healthcare facility, who produce a medical device (the final device ) where the following are satisfied:

                     (a)  a medical device production system is used to produce the final device;

                     (b)  the medical device production system is included in the Register as a kind of medical device.

2  Dictionary

Insert:

"adaptable medical device " means a mass-produced medical device that is intended by the manufacturer to be assembled or adapted after it has been supplied, in accordance with the manufacturer's instructions, to:

                     (a)  address either or both of the anatomical and physiological features of a particular individual; or

                     (b)  address a pathological condition of a particular individual; or

                     (c)  otherwise perform as intended by the manufacturer.

3  Dictionary (definition of custom-made medical device )

Repeal the definition, substitute:

"custom-made medical device " means a medical device that:

                     (a)  is intended by the manufacturer to be for:

                              (i)  the sole use of a particular patient (the intended recipient ); or

                             (ii)  the sole use of a particular health professional (the intended recipient ) in the course of the health professional's practice; and

                     (b)  is manufactured by the manufacturer in accordance with a written request of a health professional (the requesting health professional ) and with particular design characteristics specified by that health professional in the request (even if the design is developed in consultation with the manufacturer), where those design characteristics are intended to address:

                              (i)  either or both of the anatomical and physiological features of the intended recipient; or

                             (ii)  a pathological condition of the intended recipient; and

                     (c)  the requesting health professional has determined is necessary to address the matters covered by paragraph (b) because there is no kind of medical device included in the Register to address those matters or to address those matters to an appropriate level.

However, a custom-made medical device does not include a patient-matched medical device, an adaptable medical device or other mass-produced medical device.

4  Dictionary

Insert:

"mass-produced medical device " means a medical device that:

                     (a)  is manufactured according to standardised dimensions or designs; and

                     (b)  is not designed for a particular individual; and

                     (c)  is manufactured in a continuous production process or in a homogenous batch.

"medical device production system " means a system that consists of raw materials and main production equipment (whether or not the system also consists of software), where the system is intended by the manufacturer to be used (whether or not with ancillary inputs or equipment) by a health professional, or suitably qualified person within a healthcare facility, to produce a particular medical device for use in relation to a patient of the health professional or healthcare facility.

"patient-matched medical device " means a medical device that:

                     (a)  is manufactured by the manufacturer, within a specified design envelope, to match:

                              (i)  either or both of the anatomical and physiological features of a particular individual; or

                             (ii)  a pathological condition of a particular individual; and

                     (b)  is designed by the manufacturer (even if the design is developed in consultation with a health professional); and

                     (c)  is manufactured using production processes that are capable of being:

                              (i)  either or both validated and verified; and

                             (ii)  reproduced.

"specified design envelope " means m inimum and maximum dimensions, performance limits or other relevant factors that:

                     (a)  characterise a medical device for production purposes; and

                     (b)  may be based on a standard device template.

Part 2 -- Reports

Therapeutic Goods (Medical Devices) Regulations 2002

5  After regulation 10.3

Insert:

10.3A   Custom-made medical devices--information about supplies

             (1)  A person commits an offence if:

                     (a)  the person is the manufacturer of a custom-made medical device that is manufactured in Australia in a financial year (the relevant financial year ); and

                     (b)  the person does not, before 1 October in the next financial year, give the Secretary a written report that relates to all the custom-made medical devices the person manufactured in the relevant financial year and that complies with subregulation (3).

Penalty:  10 penalty units.

             (2)  A person commits an offence if:

                     (a)  the person is the sponsor of a custom-made medical device that the person imported into Australia in a financial year (the relevant financial year ); and

                     (b)  the person does not, before 1 October in the next financial year, give the Secretary a written report that relates to all the custom-made medical devices the person imported in the relevant financial year and that complies with subregulation (3).

Penalty:  10 penalty units.

             (3)  A report under this regulation must:

                     (a)  be made in accordance with a form approved, in writing, by the Secretary; and

                     (b)  contain the information that the form requires.

             (4)  Without limiting subregulation (3), the form may require details in relation to supplies of custom-made medical devices covered by paragraph (1)(b) or (2)(b).

             (5)  The Secretary must make the form available on the Therapeutic Goods Administration's website.

Part 3 -- Conformity assessment procedures

Therapeutic Goods (Medical Devices) Regulations 2002

6  Paragraph 7.1(a) of Schedule 3

After "device", insert "and to provide a copy of the statement with the device".

7  Subclause 7.2(1) of Schedule 3 (note)

Repeal the note.

8  Paragraph 7.2(2)(c) of Schedule 3

Omit "used only in relation to a particular individual", substitute "for the sole use of a particular patient".

9  Paragraph 7.2(2)(e) of Schedule 3

Omit "provided the specification", substitute "made the request".

10  Paragraph 7.2(2)(f) of Schedule 3

Omit "or construction of the device as specified by the health professional who provided the specification", substitute "of the device as specified by the health professional who made the request".

11  After subclause 7.2(3) of Schedule 3

Insert:

          (3A)  The manufacturer must provide a copy of the statement with the device.

12  Subclause 7.6(2) of Schedule 3

Repeal the subclause, substitute:

             (2)  The manufacturer must keep the statement and documentation for at least:

                     (a)  if the device is not an implantable medical device--5 years after the manufacture of the medical device to which the statement and documentation relate; or

                     (b)  if the device is an implantable medical device--15 years after the manufacture of the medical device to which the statement and documentation relate.

Part 4 -- Exemptions

Therapeutic Goods (Medical Devices) Regulations 2002

13  Regulation 1.6

Omit "given to the device by its manufacturer to identify the device and any variants", substitute "of the device".

14  Paragraph 3.11(2)(a)

Omit "or 1.5".

15  At the end of regulation 3.11

Add:

             (3)  Despite subregulation (2), this regulation applies to a custom-made medical device.

16  Paragraph 4.3F(e)

Omit "given to the device by the manufacturer", substitute "of the device".

17  Paragraph 4A.31(h)

Omit "given to the device by the manufacturer", substitute "of the device".

18  Subparagraph 1.8(2)(c)(i) of Schedule 3

Omit "(for example, the product name or model number)".

19  Subparagraph 3.5(2)(c)(i) of Schedule 3

Omit "(for example, the product name or model number)".

20  Subparagraph 5.7(2)(c)(i) of Schedule 3

Omit "(for example, the product name or model number)".

21  Subparagraph 6.6(2)(c)(i) of Schedule 3

Omit "(for example, the product name or model number)".

22  Subparagraph 6B.6(2)(c)(i) of Schedule 3

Omit "(for example, the product name)".

23  Part 1 of Schedule 4 (table item 1.5)

Repeal the item.

24  Part 2 of Schedule 4 (at the end of the table)

Add:

25  Dictionary

Insert:

"unique product identifier " of a medical device means the unique product identifier (for example, the product name or model number) given to the device by its manufacturer to identify the device and any variants.

Part 5 -- Classification rules

Therapeutic Goods (Medical Devices) Regulations 2002

26  After subregulation 3.3(5)

Insert:

          (5A)  A medical device production system has the same classification as the medical device the system is intended to produce.

27  Clause 5.4 of Schedule 2

Repeal the clause, substitute:

5.4   Medical devices that record patient images or that are anatomical models etc.

             (1)  If:

                     (a)  a medical device is intended by the manufacturer to be used to record patient images that are to be used for either or both of the following:

                              (i)  the diagnosis or monitoring of a disease, injury or disability;

                             (ii)  the investigation of the anatomy or of a physiological process; and

                     (b)  the images are to be acquired through a method that relies on energy outside the visible spectrum;

the device is classified as Class IIa.

             (2)  A medical device that is an anatomical model (whether physical or virtual) that is intended by the manufacturer to be used for either or both of the following:

                     (a)  the diagnosis or monitoring of a disease, injury or disability;

                     (b)  the investigation of the anatomy or of a physiological process;

is classified as Class IIa.

             (3)  A programmed or programmable medical device, or software that is a medical device, that is intended by the manufacturer to be used to generate a virtual anatomical model that is to be used for either or both of the following:

                     (a)  the diagnosis or monitoring of a disease, injury or disability;

                     (b)  the investigation of the anatomy or of a physiological process;

is classified as Class IIa.

Part 6 -- Essential principles

Therapeutic Goods (Medical Devices) Regulations 2002

28  Subclause 13.4(3) of Schedule 1 (at the end of the table)

Add: