Medical Device Registration Process – Australia

Medical device registration in Australia is regulated by the Therapeutic Goods Administration (TGA) under the Therapeutic Goods Act 1989. Every medical device must be listed in the Australian Register of Therapeutic Goods (ARTG) before supply.

Key Steps for Medical Device Registration in Australia

1. Classify the medical device (Class I, Is, IIa, IIb, III) based on risk.

2. Complete conformity assessment and ensure compliance with Essential Principles.

3. Appoint an Australian Sponsor for medical device registration in Australia.

4. Submit the ARTG application through TGA Business Services.

5. Pay applicable medical device registration fees.

6. Obtain TGA approval for legal supply in Australia.

After approval, medical device registration in Australia requires ongoing post-market compliance, including adverse event reporting and regulatory updates.

Proper medical device registration in Australia ensures regulatory compliance and successful market entry.