Australia – Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)

For abridgement of TGA conformity assessments and as information required for applications for ARTG inclusion

The purpose of this document is to provide an overview of how specific overseas assessments and approvals can be used by applicants for the purposes of supporting the basis for a possible abridged assessment of an application for a TGA conformity assessment certificate, or as the documentation required to be provided with applications for inclusion of medical devices (including IVDs) in the ARTG.

Overseas evidence that can be considered

Specific evidence and documentation, issued by specific overseas regulators and assessment bodies, will be considered by the TGA in relation to requests for abridgement of TGA conformity assessments or as the documentation required for applications for inclusion of medical devices in the ARTG:

• 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 (Medical devices directives1, Medical Device Regulation, or IVD Regulation)
• Decisions of the United States Food and Drug Administration (FDA)
• Approvals and licences issued by Health Canada
• Pre-market approvals from Japan (issued by the Ministry of Health, Labour and Welfare
(MHLW), Pharmaceutical and Medical Devices Agency (PMDA) or Registered Certified Body
(RCB), whatever is applicable)
• Certificates and reports issued under the Medical Device Single Audit Program (MDSAP).*
• 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)

* For MDSAP certificates and audit reports to be considered, the Australian regulatory requirements must have been covered in the audit(s), and certificates must show that the manufacturer has been assessed and found to comply with the relevant aspects of the Therapeutic Goods (Medical Devices) Regulations 2002…