Medical device reforms: Comparable overseas regulator marketing approvals

Marketing approvals and certificates from comparable overseas regulators can be considered for TGA approvals and enable medical devices to be available for patients in Australia sooner.

The following five criteria are used when considering overseas regulator assessments and approvals for Australian regulatory purposes:

1. Comparability of the regulatory framework
2. IMDRF membership
3. Life cycle approach and post-market vigilance
4. Communication and cooperation with overseas regulators
5. Expertise of the overseas regulator

From October 2018, the TGA expanded the range of international assessments and approvals from comparable overseas regulators that can be used when submitting applications for inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG).

The list of comparable overseas regulators was expanded to include the United States Food and Drug Administration, Health Canada, Japan's Ministry of Health, Labour and Welfare and Pharmaceutical and Medical Devices Agency, and Medical Device Single Audit Program (MDSAP) auditing organisations.

The TGA has long accepted certification from European notified bodies as evidence of compliance with the conformity assessment procedures, in addition to the conformity assessment certificates issued by the TGA.

The full list of comparable overseas regulators is prescribed in the Therapeutic Goods (Overseas Regulators) Determination 2018.

The TGA is also increasing the use of assessment reports as the basis for abridgement of the assessment of an application for a TGA conformity assessment certificate.

Guidance for industry

For guidance on using overseas market authorisation evidence, see:

• Use of market authorisation evidence from comparable overseas regulatory bodies for medical devices, particularly:
  • Table 1 for Evidence that may be used for abridgement of TGA conformity assessment
  • Table 2 for Information that must accompany ARTG inclusion applications, for each comparable overseas regulator for each medical device classification
• Use of market authorisation evidence from comparable overseas regulatory bodies for medical devices - questions and answers (includes examples of when TGA will conduct an application audit, and at what level)

For a list of comparable overseas regulators, see Therapeutic Goods (Overseas Regulators) Determination 2018.

Consultations

For more information see Consultations and reviews.