As a distributor selling medical devices or IVDs on the Australian market, you could be considered a “sponsor” by the Australian regulator, the Therapeutic Goods Administration (TGA). Before selling  medical devices or IVDs in Australia, you are required to obtain TGA certification, known officially as Australian Register for Therapeutic Goods (ARTG) Inclusion.

KD&A is expert on the regulations of medical devices and as a medical device regulatory consultant, KD&A can help you simplify the process for your organisation, resulting in a smoother path to market.

RECOMMENDED ROUTE FOR REGULATORY COMPLIANCE

Establish an Agreement with the Medical Device Manufacturer

Obtain Copies of Certification and Product Information

Lodge an Application for ARTG Inclusion 

Promotional Materials Review

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

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.