The changes introduce additional pathways for sponsors to seek inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG):

• Submitting application for ARTG inclusion supported by:
  • Conformity assessment certification completed by a TGA-designated body in Australia. These may be an Australian affiliate of a European notified body, or a separate organisation.
  • An overseas marketing approval where the device is:
    • assessed by a body that has been designated to undertake conformity assessment by a comparable overseas designating authority and
    • approved by a comparable overseas regulator.
• Introducing expedited review pathways for novel medical devices in certain circumstances.

Existing processes, where the TGA may undertake conformity assessment of a medical device prior to inclusion on the ARTG, and inclusion based on conformity assessment certification from European notified bodies, will continue.

The reforms will provide earlier access to new medical devices for Australian consumers and health professionals and may potentially reduce cost for industry.

No. The intention of increasing the number of pathways is to reduce burden for industry and facilitate medical devices being available to patients more quickly in Australia.

Conformity assessment certification from overseas assessment bodies will continue to be assessed against Australian requirements.

It is planned that in general, application audits will continue for particular IVD medical devices, Class III, Active Implantable Medical Devices, and selected Class IIb medical devices which have been assessed by a comparable overseas regulator or designated body. Pre-market application audits are used to ensure an appropriate level of safety of medical devices supplied in Australia. TGA will also continue post-market monitoring to ensure any safety issues which emerge after the medical device is marketed are identified and addressed.

Medical device sponsors and manufacturers will decide which pathway they wish to follow. In the case of expedited review pathways, this involves application for novel devices that are likely to provide significantly significant clinical outcomes "jumping the queue" for evaluation. TGA will determine which products are accepted into expedited review, based on criteria agreed with our stakeholders.

The TGA will develop a model similar to that in the European Union whereby there could be multiple bodies, designated by the TGA, that are able to undertake conformity assessment certification in Australia. Other countries are also looking at models which utilise designation systems for device assessments.

Expedited assessment pathways for medical devices which address unmet serious clinical need have also been developed in a number of other countries, including the USA's FDA.

Criteria will need to be developed for designated bodies to undertake conformity assessment in Australia, comparable to models used by regulators in other countries.

TGA designation of bodies to undertake conformity assessment will require the establishment of standards for technical and clinical competence and governance (including management of conflict of interest) which such bodies would need to meet in order to be designated. These standards will be developed in consultation with health care consumers, health professionals and industry.

Criteria will also need to be developed under which expedited approval of a medical device may be made. Criteria for what constitutes a ‘novel' medical device will be developed by the TGA in consultation with consumers, health professionals and industry.

Implementation and ongoing management of these pathways will require sufficient resourcing within the TGA. It is vitally important that the new accelerated pathways do not divert resources from established pathways, potentially compromising current benchmarks.

The reforms will be progressively rolled out by the TGA over the next 18 to 24 months, with new regulatory pathways for some medicines in place within 12 months.

• Fact sheet: Medical device regulatory reforms
• Fact sheets on other reforms are available