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Submissions received: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia

24 February 2020

The TGA thanks respondents who provided a submission in response to the public consultation paper Changes to a number of definitions and the scope of the medical device regulatory framework in Australia.

This consultation was related to the implementation of the Australian Government Response to the Review of Medicines and Medical Devices Regulation (MMDR), in particular Recommendation 20 that prescribes that the regulation of medical devices in Australia, wherever possible and appropriate, should be aligned with the European Union (EU) framework.

A total of twenty-one (21) submissions were received.

Summary of feedback

This consultation invited respondents to provide feedback on proposed changes to a number of definitions underpinning the medical devices regulatory framework, and proposed changes to the regulation of some products without a medical purpose to include them into the medical devices regulatory framework.

Specifically, the TGA proposed to:

  1. align the Australian regulatory definitions with the terminology used in the EU Regulation on medical devices 2017/745 (EU MD Regulation); and
  2. broaden the range of products included within the scope of the Australian medical device regulations, to align with Annex XVI of the EU MD Regulations.

There was general support for the proposals to align the Australian regulatory requirements with the EU MD Regulation. However, some respondents had specific concerns and comments about both proposals.

  • Proposed alignment of the Australian definitions with the EU MD Regulation

Submissions were broadly supportive for the proposal to align the Australian definitions with those definitions in the EU MD Regulation. However, a few respondents expressed concern about the proposed alignment of the terms 'medical device', 'accessory' and 'lay person'. For example, two respondents did not support the proposed changes to the definition of 'medical device', in particular inclusion of reference to 'products specifically intended for the cleaning, disinfection or sterilisation of devices'. However, this category of products is already considered to be an accessory to a medical device and as such are currently regulated as medical devices in Australia.

Other respondents raised issues with the proposal not to align with the EU definitions related to post-market activities. The TGA will undertake further consultation on post market related definitions as part of the separate post-market reforms consultation process during 2020.

  • Proposed regulation of products without a medical purpose

There was general support for the regulation of products without a medical purpose, with strong support for the regulation of decorative contact lenses and brain stimulation devices that do not have a stated medical purpose but are being used (or could be seen from a consumer's perspective as being used) for a medical purpose. However, there was some opposition to the regulation of products for beauty therapy, such as lasers and personal intense pulsed light (IPL) devices, with recommendations from respondents for further consultation.

Where to from here?

The feedback from the consultation will continue to inform the work to develop the proposed regulatory amendments.

The TGA intends to proceed with recommending to the Government to align some Australian regulatory definitions with the EU MD Regulations, such as for 'medical device', 'accessory', 'single use', 'user', 'reusable surgical instrument'. Some proposed definitions are related to other consultations and will be considered in the context of these consultations prior to considering further regulatory amendments (e.g. proposed changes to medical device essential principles for safety and performance).

The TGA will undertake further discussions with targeted stakeholders about the proposed regulation of products for beauty therapy, such as lasers and IPL devices, prior to considering further regulatory amendments.

Submissions received

All submissions that gave permission to be published on the TGA website are now available below in PDF format.

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