Conformity assessment requirements for Australian medical device manufacturers - streamlining requirements

21 November 2014

Commencing on 5 November 2014, Australian medical device manufacturers are able to use conformity assessment certification from European notified bodies when making applications to the TGA, as was already the case for overseas manufacturers.

Under previous arrangements Australian medical device manufacturers were required to seek a conformity assessment certificate from the TGA if they want to supply their product in Australia. With this change, whether the medical device is manufactured in Australia or overseas the manufacturer can choose to have conformity assessment conducted by:

  • the TGA; or
  • an alternative conformity assessment body, such as a European notified body.

This new approach provides more flexibility for Australian medical device manufacturers and in many cases should enable products to be available more quickly.

This also provides a more streamlined approach because Australian medical device manufacturers no longer need to duplicate conformity assessment certification from a European notified body as well as the TGA if they want to supply their device in the European market.

This change is expected to save Australian medical device manufacturers $6.12m each year by reducing regulatory burden, primarily through enabling medical devices to get to market more quickly, but also in the reduced administrative costs of complying with Australian regulatory processes. Australian manufacturers are also expected to save up to $0.98m each year in reduced TGA application and assessment fees.

TGA conformity assessment for the highest risk medical devices - those containing medicines or tissues of animal, biological or microbial origin, or Class 4 IVDs - will continue to apply as it already does for overseas manufacturers.

Approval for this change was granted as part of the Government's Industry Innovation and Competitiveness Agenda, and the amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 came into effect on 5 November 2014.

No implications for public health and safety

Under this change, Australian manufacturers must still meet high standards of safety, quality and performance for their medical devices. Australian manufacturers continue to be required to include their devices on the Australian Register of Therapeutic Goods, or ARTG, prior to supply in Australia, regardless of whether they choose to use an alternate conformity assessment body or the TGA.

The ARTG inclusion process provides for TGA scrutiny and possible audit, including compulsory audits for higher risk medical devices. Post market monitoring and compliance requirements also continue to apply for all medical devices approved for supply in Australia.

Additional information

A Regulation Impact Statement, or RIS, was prepared to support the Government's decision on this change. The RIS outlines in detail the proposal and associated costs and benefits for stakeholders. A copy of the RIS is available on the TGA website.

Additional information which may of interest to key stakeholders is included below.

TGA contact

Please contact the TGA if you require further information, or to discuss your options, by calling the Medical Devices Information Line on 1800 141 144 (freecall within Australia) or by email at devices@tga.gov.au.

Timeframe

Regulatory amendments to implement this change have been completed, and came into effect on 5 November 2014. These amendments were made to the Therapeutic Goods (Medical Devices) Regulations 2002.

Medical devices must be included on the ARTG before they can be supplied in Australia, and manufacturer's evidence must be submitted to support such applications. System changes have been made to allow sponsors of Australian manufactured medical devices to submit manufacturer's evidence from European notified bodies. If you have any issues submitting manufacturer's evidence please contact the TGA.

If you have a TGA conformity assessment applications currently being assessed, please contact the TGA to discuss your options.

Coverage of in vitro diagnostic (IVD) manufacturers

This change includes conformity assessment requirements for IVD devices. Applications to include Class 2 and Class 3 IVDs in the ARTG can rely on the same types of manufacturers' evidence already accepted for overseas manufacturers.

Class 4 IVDs continue to require TGA conformity assessment certification, as is already the case for Class 4 IVDs manufactured overseas.

Communication with manufacturers affected by this change

We will be writing to all current Australian medical device manufacturers to inform them of this change to current requirements. All Australian manufacturers with current conformity assessment applications underway should contact the TGA by email at devices@tga.gov.au as soon as possible to discuss their application and options open to them over the next few months.

If you are an Australian manufacturer without current conformity assessment certification with the TGA, please contact the TGA if you require further information. This includes any new medical device manufacturers not currently supplying devices in Australia, or those who manufacture medical devices only for export.