Australia’s TGA Releases Guidance on Registering Class IV In Vitro Diagnostics
Australia’s Therapeutic Goods Administration released guidance on its website to help sponsors through the process of registering Class IV in vitro diagnostics in the Australian Register of Therapeutic Goods.
Sponsors need to first submit manufacturer evidence, and the TGA needs to approve it, before applications can be submitted.
The agency accepts the following certificates as manufacturer’s evidence:
- A Conformity Assessment Certificate issued by the TGA for Schedule 3 Part 1 (full quality assurance) or Schedule 3 Part 4 (production quality assurance);
- An EC certificate issued by an EU Notified Body for Annex IV.3 (full quality assurance) or Annex VII (production quality assurance) of the EU IVDD 98/79/EC; or
- An ISO 13485 medical devices quality management system certificate. A compliance certificate can be issued by a certification body that is also a Notified Body for the purposes of the IVDD 98/79/EC, a Canadian Medical Devices Conformity Assessment System recognized registrar or a certification body that is accredited by a signatory of the International Accreditation Forum Multilateral Recognition Arrangement to perform ISO 13485 certification. — Tamra Sami