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’.
The 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.
Australian based KD&A are TGA experts who understand the Australian medical device and IVD market. With KD&A as your sponsor you can be confident that Australian regulatory compliance will be expertly managed and maintained.
Recommended Route to Regulatory Compliance
KD&A provide Sponsor Services. This service allows you to meet regulatory requirements by using KD&A’s address on your product’s packaging or labelling.
Lodge an Application for ARTG Inclusion
Once KD&A is established as a sponsor for your organisation, we will complete application for ARTG inclusion on your behalf. 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.
Note: This process does not apply to IVD manufacturers . For information on the IVD requirements contact KD&A.
Prior to supplying your medical device on the Australian market KD&A recommend the following additional services.
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 design and create a Post Market Surveillance System for your organisation, which will assist you to complete both reactive and proactive post market activities.