International Manufacturers

To place a medical device or IVD on the Australian market, non-Australian based manufacturers must appoint a local agent and obtain Therapeutic Goods Administration (TGA) certification. The TGA term for a local agent is a ‘sponsor’.

flow-chart-international-manufacturer-300x225The sponsor’s role is to act on your behalf in all TGA related situations, including any compliance issues that may arise resulting from the sale of your products on the Australian market. The sponsor’s details must appear on product labelling or packaging.

While any Australian resident or registered business can play the role of a sponsor, it is prudent to select a sponsor familiar with TGA regulations. You need to know that you can rely upon your sponsor to react appropriately and within mandatory response times. KD&A can provide guidance to ensure your elected sponsor understands the requirements of Australian sponsors if required.

We are TGA agents who are expert on the Australian medical device and IVD market. With KD&A as your TGA agent, you can be confident that Australian regulatory compliance will be expertly managed and maintained.

RECOMMENDED ROUTE TO REGULATORY COMPLIANCE

Lodge an Application for ARTG Inclusion

Once a sponsor is established as a sponsor for your organisation, KD&A will complete application for ARTG inclusion. This application will be dependent on device type and classification, and will be submitted to the TGA. KD&A can also review supporting Technical Documentation (also known as a Technical File or Design Dossier) held by your organisation to ensure compliance with TGA requirements.

Once an ARTG inclusion is obtained, you can begin to supply your medical device on the Australian market.

Prior to supplying your medical device on the Australian market KD&A recommend the following additional services.

Promotional Materials Review

Ensure your product’s promotional materials (including labelling and packaging) comply with the Therapeutic Goods Advertising Code.

Post Market Surveillance System

It is a mandatory TGA requirement and a condition of medical device ARTG inclusion that sponsors complete post market surveillance. KD&A can assist you with the development of a compliant Post Market Surveillance system that is tailored to your organisation.