ATTACHMENT

 

Details of the proposed Therapeutic Goods (Medical Devices) Amendment (Australian Manufacturers) Regulation 2014

 

Section 1 - Name of Regulation

This section provides for the regulation to be referred to as the Therapeutic Goods (Medical Devices) Amendment (Australian Manufacturers) Regulation 2014.

 

Section 2 - Commencement

This section provides for the regulation to commence on 5 November 2014.

 

Section 3 - Authority

This section provides that the regulation is made under the Therapeutic Goods Act 1989 (the Act).

 

Section 4 - Schedule(s)

This section provides that each instrument that is specified in a Schedule to the regulation is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the regulation has effect according to its terms.

 

 

Schedule 1 - Amendments of the Therapeutic Goods (Medical Devices) Regulations 2002

 

Therapeutic Goods (Medical Devices) Regulations 2002

 

Items 1 and 2 - Regulation 3.5 (heading) and subregulation 3.5(1)

These items make a minor, consequential change to subregulation 3.5(1), and introduce a new heading for regulation 3.5, of the Principal Regulations.

 

Subregulation 3.5(1) allows a power or function of the Secretary in relation to assessing whether an overseas manufacturer has correctly applied relevant manufacturing standards (known as 'conformity assessment procedures') in their production processes to be exercised by a body or authority (including a private conformity assessment body) that the Secretary is satisfied has appropriate expertise to do so.

 

These powers and functions include, for example, assessing whether a device manufacturer has implemented a quality management system for the design, production, packaging, labelling and final inspection of its devices.

 

Item 2 removes the reference in subregulation 3.5(1) to overseas manufacture, with the effect that Australian manufacturers can also use the services private conformity assessment bodies to conduct such assessments.

 

Item 1 introduces a new heading for regulation 3.5(1) to reflect the removal of the reference to medical devices manufactured outside Australia.

 

Item 3 - Subregulation 4.1

This item repeals subregulation 4.1(1) of the Principal Regulations, thus removing the current requirement in that provision for all Australian medical device manufacturers to have applied for, and been issued, a conformity assessment certificate before marketing approval can be sought for their devices.

 

The effect of this item, taken together with the amendment made by item 6, is to place Australian medical device manufacturers on the same footing as overseas manufacturers - i.e. device manufacturers, whether based in Australia or overseas, will only need a conformity assessment certificate issued by the TGA if they are engaged in the manufacture of certain kinds of medical devices (listed in paragraphs 4.1(2)(a)-(e)).

 

Item 4 - Subregulation 4.1(2)

This item makes a minor formatting change to subregulation 4.1(2) as a consequence of the amendments made by items 3 and 7.

 

Item 5 - Subregulation 4.1(2)

This item makes a minor formatting change to subregulation 4.1(2) as a consequence of the amendment made by item 7.

 

Item 6 - Subregulation 4.1(2)

Currently under subregulation 4.1(2) of the Principal Regulations, a conformity assessment certificate must have been issued by the TGA before marketing approval can be sought for certain kinds of medical devices that are manufactured overseas - e.g. medical devices (other than in vitro diagnostic medical devices) containing non-viable tissues of animal origin.

 

Item 6 removes the reference to overseas manufacture from subregulation 4.1(2), with the effect that subregulation 4.1(2) applies to require any medical device manufacturer engaged in the production of one of these kinds of devices to obtain a conformity assessment certificate, whether they are based overseas or in Australia.

 

Item 7 - Subregulation 4.1(3)

Item 7 repeals subregulation 4.1(3), principally as a consequence of the repeal of subregulation 4.1(1).

 

Subregulation 4.1(3) exempts specified kinds of medical devices from the requirement in subregulations 4.1(1) and (2) to obtain a conformity assessment certificate. With the repeal of subregulation 4.1(1), subregulation 4.1(3) is no longer necessary.

 

In addition, some of the kinds of devices in subregulation 4.1(3) do not require a conformity assessment certificate in any event, as they are devices which, under the Act, are not required to be included in the Australian Register of Therapeutic Goods (the Register) - e.g. devices approved under section 41HB of the Act for use solely in clinical trials.

 

Item 8 - Subparagraph 5.3(1)(j)(viii)

Item 8 replaces current subparagraph 5.3(1)(j)(viii) of the Principal Regulations with a new subparagraph of that number, incorporating a minor, consequential change to reflect the amendments introduced by item 2 above.    

 

Subparagraph 5.3(1)(j)(viii) currently requires the Secretary to audit an application for the inclusion in the Register of an in vitro diagnostic medical device manufactured overseas in specified circumstances.  Those circumstances are where the device is one in relation to which the Secretary is not satisfied, under subregulation 3.5 of the Principal Regulations, that a private conformity assessment body has the expertise and authority to assess the suitability of the manufacturing processes of the overseas manufacturer of the device.    

 

As item 2 amends subregulation 3.5 to remove any distinction between medical devices manufactured in Australia or overseas in relation to the Secretary's ability to authorise a private body to assess manufacturing processes, there is a need to also amend subparagraph 5.3(1)(j)(viii) to the same end.

 

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

 

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

This legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Legislative Instrument

The Therapeutic Goods (Medical Devices) Amendment (Australian Manufacturers) Regulation 2014 (the Amendment Regulation) is made under subsection 63(1) of the Therapeutic Goods Act 1989 (the Act). Under section 41EA of the Therapeutic Goods Act 1989 and subregulation 4.1(1) of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Principal Regulations), an application for marketing approval cannot be made for a medical device manufactured in Australia unless the manufacturer has applied to the Therapeutic Goods Administration (TGA) for, and been issued, a conformity assessment certificate.  This contrasts with devices manufactured overseas, for which a TGA conformity assessment certificate is only required before an application can be made for marketing approval if the device involved is of a higher risk type described in paragraphs 4.1(2)(a)-(e) of the Principal Regulations.

 

Conformity assessment certificates signify a range of matters about the manufacture of the devices to which they relate, e.g. that they comply with minimum requirements for performance and safety, and that relevant manufacturing standards are being observed in the manufacturing process. Sponsors of devices must certify that their devices comply with these requirements when applying for marketing approval, and conformity assessment certificates substantiate that compliance for manufacturers required to obtain them. Overseas manufacturers, however, are able to use the services of private conformity assessment bodies to verify such matters.

 

The purpose of the Amendment Regulation is to amend the Principal Regulations to place Australian manufacturers on the same footing as overseas manufacturers in regard to the need for conformity assessment certificates for medical devices other than those higher risk devices mentioned above, providing Australian manufacturers with greater flexibility in relation to demonstrating compliance with conformity assessment compliance and benefits such as a reduction in associated administrative costs.      

 

Human rights implications

As the Amendment Regulation does not introduce any changes to the Principal Regulations other than to implement the measure outlined above, it does not engage any of the applicable rights or freedoms.

Conclusion

This legislative instrument is compatible with human rights as it does not raise any human rights issues.

Fiona Nash

Assistant Minister for Health