Australia

1. Authorities

The regulatory authority responsible for medical device registration in Australia is the Therapeutic Goods Administration, or TGA for short.

2. Relevant Regulations

Different classification guidelines will be used according to the different classifications of medical device products.

Medical device MD classification: Class I /Class Is /Class Im/Class IIa/Class IIb/Class III

IVD classification of in vitro diagnostic medical devices: Class 1/Class 2/Class 3/Class 4

3. Time estimation

The average review time for low-risk products (Class I & Class I & Class 2) is 2-4 months, and the average review time for high-risk products (Class 3 or above) is 6-12 months.

4. Local Representatives

Overseas manufacturers outside of Australia must appoint a local authorized representative, called a "sponsor"

5. Successful Cases

20+ Customer Success Cases