Conformity Assessment Procedures for Medical Devices, Proposed Amendments

The Therapeutic Goods Administration (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 the regulatory framework (wherever possible) and to participate in the Medical Devices Single Audit Program (MDSAP). This consultation is part of the ongoing reform program.

This consultation seeks views on where appropriate 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), collectively referred to as the European Regulations. The TGA has reviewed the current Australian conformity assessment procedures against the European Regulations (see Appendix 1 for details of the comparison) and propose alignment with the European Regulations, where practicable.

This consultation also seeks feedback on proposed stronger 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.

Please fill out your input in the form below by March 27th so we have ample time to collate the responses. You may also share additional comments in the discussion box below to contribute to a collaborative conversation with other members.