Australia mulls green-lighting overseas-approved devices

Australia’s Therapeutic Goods Administration this week proposed to allow the marketing of medical devices that already won approval in certain other jurisdictions.

Under the proposal, devices approved by authorities in countries that are part of the International Medical Device Regulators Forum would be allowed onto the TGA’s Register of Therapeutic Goods. In addition to Australia and the U.S., the IMDRF’s members are Brazil, Canada, China, Europe, Japan, Russia and Singapore.

“The Government has decided that the TGA should make greater use of marketing approvals for devices in overseas markets when the device has been approved by a 3rd party that has been designated by an authority that is similar to the TGA or by a comparable overseas regulator,” according to the proposal.

The public comment period on the proposal, including the criteria for choosing which overseas regulators to include, closes June 30, the TGA said.

“The purpose of the criteria is to identify regulators with similar standards to the TGA, and to allow confidence in the assessment undertaken by the regulator or the 3rd parties that are oversighted by them, so as to avoid duplication of work in Australia without compromising public safety,” the agency said.

The criteria include:

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

Any changes to the TGA’s protocols would come after the public comment period and the passage of legislation enacting the changes, the TGA said, with the new rules slated to take effect in January 2018.

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