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MMDR: Medical devices regulatory reforms

3 March 2020

Reforms to the regulation of medical devices are being implemented in response to the recommendations arising from the Review of Medicines and Medical Devices Regulation.

The reforms include changes that will provide Australians with earlier access to new medical devices and enhance post-market surveillance.

Reforms that have been implemented

Priority review pathway for medical devices

The new priority review pathway allows applications for either TGA conformity assessment, or inclusion of a medical device in the Australian Register of Therapeutic Goods, to be considered for priority review designation and ‘front-of-queue’ assessment.

Aligning the medical device regulatory framework with the European Union

The first stage in aligning medical device regulations with the European Union framework included changes to the regulation of surgical mesh devices and the requirements for consumer information for all implantable medical devices.

Comparable overseas regulators: medical devices

New processes will allow the use of approvals from comparable international regulators to support the inclusion of medical devices in the Australian Register of Therapeutic Goods.

Upcoming reforms

Australian conformity assessment bodies

Changes allowing Australian ‘notified bodies’ to undertake conformity assessment certification of medical devices.