Consultation: Conformity Assessment Procedures for Medical Devices | Proposed Amendments

Overview

The TGA has been systematically reviewing the way medical devices are regulated. This has been guided by An Action Plan for Medical Devices which is a three-part strategy to strengthen Australia’s regulatory system while continuing to be patient focused and have greater transparency.

The Australian Government is also committed to improve how medical devices are regulated by internationally aligning our regulatory framework (wherever possible) and to participate in the Medical Devices Single Audit Program (MDSAP).

We have been reviewing where alignment should occur with the conformity assessment procedures of the European Regulation 2017/745 on medical devices (MDR) and the European Regulation 2017/746 for in vitro diagnostic medical devices (IVDR).

This project also looks to enhance our alignment with the guidance published by the International Medical Device Regulators Forum (IMDRF) and the regulatory approach of countries that are members of the MDSAP. In addition to the TGA, the MDSAP members include the medical device regulators from Brazil, Canada, Japan and the United States of America (US), as well as an increasing number of observer and affiliate regulatory authority members from other countries. As a member of the MDSAP, alignment with the other participating regulatory authorities, where possible, will ensure Australia realises the full benefits of this rapidly growing program.

Why your views matter

Your views and feedback will help inform any changes to our practices, guidance or legislation relevant to medical devices. In addition to the scope of this consultation, we welcome feedback on our consultation process.

You can review the consultation on our consultation hub and submit your feedback by using our online survey tool or email your response to devicereforms@tga.gov.au.