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

This Guidance explains how overseas assessments can support our medical device certification and registration processes.

Published
Last updated

Purpose

The purpose of this guidance is to provide an overview of how specific overseas assessments and approvals can be used by applicants for:

  • supporting 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.

Legislation

Guidance

This Guidance is presented as downloadable files because of its wide table format. 

Downloads

Product types

Page history

Show all page updates (13)

Amendments to reflect recent updates to the Determination as part of changes to Regulation 5.3 on 1 July 2024 and the TGA strategy to manage further extension to the EU IVDR transition timelines. 

Amendments to reflect the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment (European Union—Class IIa and Class IIb) Determination 2023.

Corrections, and to reflect end of acceptance of most ISO 13485 certificates for IVDs.

Amendments to clarify the requirements for EUMDR. 

Amendments to include Singapore HSA as a comparable overseas regulator.

Amendments to reflect the extended acceptance of ISO13485 certificates as manufacturer evidence for IVD applications in line with EU IVDR (207/746).

Amendments to reflect the repeal of Therapeutic Goods (Medical Devices) Regulations 2002, Regulation 4.1 (requirement for TGA conformity assessment for medical devices containing medicines or materials of animal, microbial, recombinant or human origin, or Class 4 IVDs.

Amendments to reflect changes to application process and requirements for inclusion of Class I non-sterile, non-measuring devices.

Insertion of links to legislative instruments and related notations.

Further clarification on acceptable ISO 13485:2016 certificates for IVD medical devices. 

Removal of requirement for attachment of Health Canada Medical licence listing for applications for Class 2 and Class 3 IVD medical devices (to pass preliminary assessment). 

Removal of CMDCAS reference for medical devices (that is, non-IVD medical devices).

Clarification of acceptable ISO 13485 certificates for IVD medical devices.

Original publication.

Amendments to reflect recent updates to the Determination as part of changes to Regulation 5.3 on 1 July 2024 and the TGA strategy to manage further extension to the EU IVDR transition timelines. 

Amendments to reflect the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment (European Union—Class IIa and Class IIb) Determination 2023.

Corrections, and to reflect end of acceptance of most ISO 13485 certificates for IVDs.

Amendments to clarify the requirements for EUMDR. 

Amendments to include Singapore HSA as a comparable overseas regulator.

Amendments to reflect the extended acceptance of ISO13485 certificates as manufacturer evidence for IVD applications in line with EU IVDR (207/746).

Amendments to reflect the repeal of Therapeutic Goods (Medical Devices) Regulations 2002, Regulation 4.1 (requirement for TGA conformity assessment for medical devices containing medicines or materials of animal, microbial, recombinant or human origin, or Class 4 IVDs.

Amendments to reflect changes to application process and requirements for inclusion of Class I non-sterile, non-measuring devices.

Insertion of links to legislative instruments and related notations.

Further clarification on acceptable ISO 13485:2016 certificates for IVD medical devices. 

Removal of requirement for attachment of Health Canada Medical licence listing for applications for Class 2 and Class 3 IVD medical devices (to pass preliminary assessment). 

Removal of CMDCAS reference for medical devices (that is, non-IVD medical devices).

Clarification of acceptable ISO 13485 certificates for IVD medical devices.

Original publication.