Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 (Cth)

Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018

I, General the Honourable Sir Peter Cosgrove AK MC (Ret’d), Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations.

Dated 19 April 2018

Peter Cosgrove

Governor‑General

By His Excellency’s Command

Greg Hunt

Minister for Health

Contents

1Name

This instrument is the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018.

2Commencement

1. (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.

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1. The whole of this instrument	The day after this instrument is registered.	27 April 2018

Note: This table relates only to the provisions of this instrument as originally made.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.

1. (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.

3Authority

This instrument is made under the Therapeutic Goods Act 1989.

4Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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

Therapeutic Goods (Medical Devices) Regulations 2002

1

In the appropriate position in Part 11

Insert:

Division 11.7—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018

11.34Application of amendments

The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a medical device imported into Australia:

1. (a)

   on or after the commencement of this regulation; or

2. (b)

   during the 12 months ending immediately before that commencement, if the device was held under the direct control of the sponsor immediately before that commencement.

1. 2

   Part 2 of Schedule 4 (table item 2.1, column headed “Kinds of medical devices”, paragraph (b))

After “41HB”, insert “or 41HD”.

1. 3

   Part 2 of Schedule 4 (at the end of the cell at table item 2.1, column headed “Kinds of medical devices”)

Add:

; or (e) exported from Australia

1. 4

   Part 2 of Schedule 4 (table item 2.1, column headed “Conditions”, paragraph (c))

Repeal the paragraph.

1. 5

   Part 2 of Schedule 4 (table item 2.1, column headed “Conditions”, subparagraph (d)(ii))

Repeal the subparagraph.

Therapeutic Goods Regulations 1990

6

In the appropriate position in Part 9

Insert:

Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018

63Application of amendments

The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:

1. (a)

   on or after the commencement of this regulation; or

2. (b)

   during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.

1. 7

   Schedule 5A (table item 1, column 2, paragraph (b))

Omit “or 32CK(1)”, substitute “, section 19A, subsection 32CK(1) or section 32CO”.

1. 8

   Schedule 5A (at the end of the cell at table item 1, column 2)

Add:

; or (e) exported from Australia

1. 9

   Schedule 5A (table item 1, column 3, paragraph (c))

Repeal the paragraph.

1. 10

   Schedule 5A (table item 1, column 3, subparagraph (d)(ii))

Repeal the subparagraph.