Breaking News: TGA recognises other reference approvals in addition to EU CE for ARTG listing

Australia: 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 directives, 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).

The documentation should be issued by an overseas regulator or assessment body for the same medical device as you are applying for in Australia with:

• the same design,

• the same intended purpose, and

• intended for the same indications.

Table1 and Table 2 in this guidance specify what documentation can be utilised for what purpose:

• Table 1 - Documents for abridgement of TGA conformity assessment

• Table 2 - Information that must accompany ARTG inclusion applications

Above information takes reference from:

http://www.tga.gov.au/publication/use-market-authorisation-evidence-comparable-overseas-regulators-assessment-bodies-medical-devices

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