Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021

I, General the Honourable David Hurley AC DSC (Retd), Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations.

Dated 16 December 2021

David Hurley

Governor‑General

By His Excellency’s Command

Greg Hunt

Minister for Health and Aged Care

Contents

1 Name

2 Commencement

3 Authority

4 Schedules

Schedule 1—Amendments

Part 1—Medical devices

Therapeutic Goods (Medical Devices) Regulations 2002

Part 2—Other amendments

Division 1—Amendments commencing on day after registration

Therapeutic Goods Regulations 1990

Division 2—Amendments commencing on 1 January 2022

Therapeutic Goods Regulations 1990

1  Name

  This instrument is the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021.

2  Commencement

 (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

 (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

  This instrument is made under the Therapeutic Goods Act 1989.

4  Schedules

  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

Part 1—Medical devices

Therapeutic Goods (Medical Devices) Regulations 2002

1  In the appropriate position in Part 11

Insert:

Division 11.14—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021

11.67  Patient implant cards and patient information leaflets

  The amendments of clause 13A.1 of Schedule 1 made by Part 1 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to a medical device that is imported, supplied or exported on or after the commencement of that Part.

2  Clause 13A.1 of Schedule 1

Before “Clauses”, insert “(1)”.

3  At the end of clause 13A.1 of Schedule 1

Add:

 ; and (c) not a medical device to which subclause (2) applies.

 (2) This subclause applies to a medical device if:

 (a) the medical device is intended by the manufacturer to be wholly, or mostly, absorbed by a patient’s body within 6 months of being implanted; and

 (b) the medical device is:

 (i) for use as a filler; or

 (ii) for haemostasis; or

 (iii) for tissue approximation; or

 (iv) for the fixation of other medical devices within tissue; or

 (v) a similar medical device to a medical device covered by subparagraph (i), (ii), (iii) or (iv).

4  Part 2 of Schedule 4 (table item 2.16, column headed “Kinds of medical devices”, subparagraph (c)(ii))

Omit “Class I medical devices”, substitute “Class I, Class IIa, Class IIb or Class III medical devices”.

Part 2—Other amendments

Division 1—Amendments commencing on day after registration

Therapeutic Goods Regulations 1990

5  Paragraph 7(g)

After “Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002”, insert “(except items 2.12, 2.13, 2.14 and 2.15 of that Part)”.

6  Subregulation 12B(1B) (cell at table item 45A, column 4)

Repeal the cell, substitute:

7  Subregulation 12B(1B) (cell at table item 46B, column 2)

Repeal the cell, substitute:

8  Subregulation 12B(1B) (cell at table item 72A, column 2)

Repeal the cell, substitute:

9  In the appropriate position in Part 9

Insert:

Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021

84  Amendments made by Division 1 of Part 2 of Schedule 1

 (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.

 (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.

10  Schedule 5A (table item 1B, column 3, paragraph (a))

Repeal the paragraph, substitute:

Division 2—Amendments commencing on 1 January 2022

Therapeutic Goods Regulations 1990

11  Subregulation 6B(1)

Repeal the subregulation, substitute:

Prohibited representations

 (1) For the purposes of subsection 42DJ(1) of the Act:

 (a) the representations in column 2 of an item in the table in Part 1 of Schedule 2 are specified; and

 (b) the therapeutic goods in column 3 of that item are specified.

Note: Under subsection 42DJ(1) of the Act, those representations about those goods are prohibited representations.

12  Before subregulation 6B(2)

Insert:

Required representations

13  Regulation 8

Omit “sections 9, 10, 15, 16, 18, 19 and 21”, substitute “sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26”.

14  Regulation 8 (note)

Omit “section 6”, substitute “sections 5 and 6”.

15  At the end of Division 17 of Part 9

Add:

85  Amendments made by Division 2 of Part 2 of Schedule 1

 (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.

 (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.

16  Part 1 of Schedule 2 (table item 4)

Repeal the item, substitute:

17  Part 1 of Schedule 2 (table item 8)

Repeal the item, substitute:

18  Part 1 of Schedule 2 (at the end of the table)

Add: