Australia: TGA Presents Conformity Assessment Bodies & Inclusion of Medical Devices Process in ARTG

ARQon
Sep 20, 2021
1 min read

TGA Presents Conformity Assessment Bodies

In July 2021, the Australian government agreed to regulatory amendments that will allow other Australian corporations with relevant experience and competence to conduct medical device conformity assessments. This amendment is to bring flexibility and timeliness as previously, Australian medical device manufacturers could only apply for a conformity assessment certificate from either the TGA or an overseas Notified Body.

The TGA is still in charge of registering medical devices in Australia's Therapeutic Goods Register (ARTG). The TGA will also continue to offer product assessments and quality management assessments when required by legislation or requested by a manufacturer.

Inclusion of Medical Devices Procedure in ARTG

The TGA regulates medical devices, including IVD medical devices in compliance with the Therapeutic Goods Act 1989, the Therapeutic Goods (Medical Devices) Regulations 2002, and the Therapeutic Goods Regulations 1990. Before a medical device can be legally imported into, distributed within, or exported from Australia, it must first be listed in the ARTG (unless it is exempted or excluded by the Act) including prior to applying for a Certificate of Free Sale or an Export Certificate. TGA has published a guidance which is intended for sponsors applying for inclusion of a 'kind of medical device', including IVD medical devices, in the ARTG.

Sources:

Medical devices reforms: Conformity assessment bodies

Australian conformity assessment bodies

Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018

Part 4A—Australian conformity assessment bodies

Medical device inclusion process