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
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.
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.
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.
Changes allowing Australian 'notified bodies' to undertake conformity assessment certification of medical devices.
All consultations related to the Medicines and Medical Devices Regulation Review.
Consultations related to medical devices
- Update on reclassification of a number of medical devices
- Alignment with European medical device regulatory framework: Up-classification of surgical mesh & Patient implant cards
- Use of overseas regulatory approvals for medical devices and criteria for identifying comparable overseas designating authorities and regulators
- Designation of Australian conformity assessment bodies for medical devices
- Accelerated assessment of medical devices - priority review
Up-to-date information about the reforms and their status.
Information on the Review of Medicines and Medical Devices Regulation, including links to the complete Review and the Australian Government's response.