In Australia, a local representative plays a crucial role in the registration and ongoing regulatory compliance of medical devices and diagnostics that are imported or supplied from overseas. The role of a local representative typically includes:
1. Regulatory Liaison: Acting as a point of contact between the overseas manufacturer and the Australian regulatory authority, the Therapeutic Goods Administration (TGA).
2. Device Registration: Assisting with the registration process of the medical device or diagnostic with the TGA, including submitting applications and supporting documentation.
3. Post-Market Surveillance: Facilitating communication between the overseas manufacturer and the TGA regarding post-market surveillance activities, including reporting of adverse events and field safety corrective actions.
4. Complaint Handling: Managing complaints and inquiries related to the medical device or diagnostic in Australia, in accordance with TGA requirements.
5. Record Keeping: Maintaining records of the device registration, post-market surveillance activities, and other relevant documentation as required by the TGA.
6. Compliance Support: Providing support and guidance to ensure ongoing compliance with TGA regulations, including changes in regulatory requirements or standards.
The appointment of a local representative is a regulatory requirement for certain medical devices and diagnostics in Australia, particularly those imported or supplied from overseas. The local representative must be based in Australia and be authorized to act on behalf of the overseas manufacturer in regulatory matters.
