Key Steps for TGA Medical Device Certification and Market Approval

Certifying your device for the Australian market involves careful planning. Follow these five steps to ensure compliance and obtain TGA approval:

1. Determine your device classification.

Follow the classification rules that are outlined in Schedule 2 and Schedule 2A of the Therapeutic Goods Medical Devices Regulations to accurately classify your device. You can also leverage TGA’s interactive online tool to assist with the classification process. 

2. Appoint a local sponsor.

If you do not have a physical operation in Australia, appoint a local sponsor to serve as a liaison between the TGA and your organization. This representative will be responsible for submitting a medical device application to be included in the ARTG. Once the device is added to the ARTG, sponsors will be responsible for post-market surveillance activities including adverse event reporting.

3. Update your quality management system.

Compile the necessary QMS documentation (including the technical file) and perform internal audits to ensure compliance. 

4. Undergo the appropriate conformity assessment route for your device.

Determine if your device requires a comprehensive review by the TGA or if you can expedite the process using an existing certification from a comparable regulator. Equivalent assessment bodies include:

• Notified bodies under the EU MDR and EU IVDR
• U.S. FDA
• Health Canada
• Japan’s Ministry of Health, Labour and Welfare (MHLW), Pharmaceutical and Medical Devices Agency (PMDA)
• Singapore’s Health Sciences Authority (HSA)
• Medical Device Single Audit Program (MDSAP)

5. Apply to include your device in the ARTG.

Once the application is approved, your device will be added to the ARTG. The TGA will issue your device’s ARTG listing number and certificate.