On July 26, 2019, the TGA has released a Version V1.3 of its guidance “Use of market authorization evidence from comparable overseas regulators/assessment bodies for medical devices (including IVDs)”. Overseas evidence that can be considered now list EU ISO 13485:2016 certificates and gives further clarification on their acceptability:
- Certificates issued by Notified Bodies designated by the medical device regulators of European member states, under the medical device regulatory frameworks of the European Union
- ISO 13485:2016 certificates issued by a certification body that is also a Notified Body designated under the IVDD 98/79/EC (for IVD inclusion applications only until 26 May 2022)
- ISO 13485:2016 certificates issued by a body that is an accredited body that is a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum (IAF MLA) (for IVD inclusion applications only until 26 May 2022).
According to TGA, the agency will keep a close eye on the readiness and availability of Notified Bodies in Europe and will consider further amendments in Australia, if necessary.