Now that we are going to walk out of 2021, let’s prospect on the bright spots focused by the Therapeutic Goods Administration (TGA) for changes or reforms in the year to come:

1. Complete the implementation of business processes to enable Australian Conformity Assessment Bodies to provide conformity assessment for medical devices.

2. Implement the reclassification of devices to align with the European Union Medical Device Reforms where appropriate.

3. Undertake further preparation for the introduction of a Unique Device Identifier system.

4. Continue to improve post-market monitoring systems for medical devices, including early detection and action on emerging safety issues, thereby allowing us to notify consumers earlier.

5. Continue to implement the Action Plan for Medical Devices. These reforms will improve how devices get on the market, strengthen the monitoring and follow-up of devices already in use, and provide more information to patients about the devices they use.

6. Conduct public consultations, and provide advice to Australian Government on the:

a. requirements for medical devices to be used in clinical trials

b. potential inspections of the systems used by sponsors for reporting and tracking adverse events, and

c. enhancements to adverse event reporting, including whether adverse event reporting by healthcare facilities should be mandated.


If you are keen to explore the Australia medical device market in the coming year, Qualtech is there, by your side, to guide you step-by-step. We will ensure the process of breaking into this new market is smooth and effortless. Feel free to contact us to discuss your new year regulatory plans.




Australian conformity assessment bodies (Australian CABs) - Medical devices and IVDs

Medical devices reforms: Reclassification of certain medical devices - Project status: in progress

Medical device reforms: Establishment of a Unique Device Identification system - Project status: in progress

Progress update: Improving post-market monitoring and surveillance of medical devices

Medical devices reforms: An Action Plan for Medical Devices

Clinical trials

Reporting adverse events