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Comparable overseas regulators for medical device applications

20 August 2018

The TGA is expanding the range of international assessments and approvals from comparable overseas regulators that sponsors can choose to provide when submitting their applications for inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG). 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.

The Expert Review of Medicines and Medical Devices Regulation (MMDR) made recommendations aimed at streamlining the TGA's processes for including medical devices in the ARTG in order to improve access by Australian consumers to new medical devices. The Government decided that the TGA should make greater use of marketing approvals for devices in overseas markets when the device has been approved by a third party that has been designated by an authority that is similar to the TGA, or by a comparable overseas regulator (in line with MMDR Recommendation 15, Pathways 2A & 2B).

To date, the TGA has been accepting 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.

From August 2018*, the number of comparable overseas regulators and assessment bodies will be expanded to:

  • Notified bodies designated by the medical device regulators of European member states, under the medical device regulatory frameworks of the European Union
  • the Food and Drug Administration of the United States
  • Health Canada
  • Medical Device Single Audit Program (MDSAP) Auditing Organisation
  • the Ministry of Health, Labour and Welfare and Pharmaceutical and Medical Devices Agency of Japan.

*This date will be finalised (and this page updated) once the relevant legislative instrument(s) are in place.

Using overseas market authorisation evidence

In consultation with the medical devices industry, the TGA has developed guidance which provides an overview on the use of specific overseas assessments and approvals by sponsors in their applications for ARTG inclusion and when they request the abridgement of applications for TGA conformity assessment certification:

We have also developed a number of questions and answers to provide applicants with examples of when TGA will conduct an application audit, and at what level.