Federal Register of Legislation - Australian Government

Primary content

SLI 2014 No. 159 Regulations as made
This regulation amends the Therapeutic Goods (Medical Devices) Regulations 2002 to allow third party conformity assessment for Australian medical device manufacturers, giving them the same capacity as overseas manufacturers to utilise private conformity assessment bodies to demonstrate conformity assessment compliance in relation to medical devices approved for supply in, or export from, Australia.
Administered by: Health
Registered 03 Nov 2014
Tabling HistoryDate
Tabled HR14-Nov-2014
Tabled Senate17-Nov-2014
Date of repeal 06 Nov 2014
Repealed by Division 1 of Part 5A of the Legislative Instruments Act 2003
Table of contents.

 

Therapeutic Goods (Medical Devices) Amendment (Australian Manufacturers) Regulation 2014

 

Select Legislative Instrument No. 159, 2014

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 regulation.

Dated 30 October 2014

Peter Cosgrove

Governor‑General

By His Excellency’s Command

Fiona Nash

Assistant Minister for Health

  

  


Contents

1............ Name................................................................................................... 1

2............ Commencement................................................................................... 1

3............ Authority............................................................................................. 1

4............ Schedules............................................................................................ 1

Schedule 1—Amendments                                                                                                2

Therapeutic Goods (Medical Devices) Regulations 2002                                   2

 


1  Name

                   This is the Therapeutic Goods (Medical Devices) Amendment (Australian Manufacturers) Regulation 2014.

2  Commencement

                   This instrument commences on 5 November 2014.

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                   Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 1Amendments

  

Therapeutic Goods (Medical Devices) Regulations 2002

1  Regulation 3.5 (heading)

Repeal the heading, substitute:

3.5  Powers and functions of Secretary in relation to conformity assessment

2  Subregulation 3.5(1)

Omit “that is manufactured outside Australia”.

3  Subregulation 4.1(1)

Repeal the subregulation.

4  Subregulation 4.1(2)

Omit “(2)”.

5  Subregulation 4.1(2)

Omit “and subject to subregulation (3)”.

6  Subregulation 4.1(2)

Omit “manufactured outside Australia”.

7  Subregulation 4.1(3)

Repeal the subregulation.

8  Subparagraph 5.3(1)(j)(viii)

Repeal the subparagraph, substitute:

                          (viii)  if the Secretary is not satisfied that a body or authority has the authority and expertise to exercise a power or perform a function of the Secretary mentioned in subregulation 3.5(1)—an IVD medical device that has been manufactured in a location and at a site where that body or authority has exercised such a power or performed such a function in relation to the device.