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MMDR: Medical devices regulatory reforms

22 November 2021

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 TGA can now issue priority applicant determinations related to specific medical devices, in order to speed up the assessment of applications for inclusion in the Australian Register of Therapeutic Goods, or processes of TGA conformity 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.

Further information

MMDR consultations

All consultations related to the Medicines and Medical Devices Regulation Review.

Consultations related to medical devices

Overview of program status for the MMDR reforms

Up-to-date information about the reforms and their status.

MMDR background information

Information on the Review of Medicines and Medical Devices Regulation, including links to the complete Review and the Australian Government's response.