As a distributor selling medical devices or IVDs on the Australian market, you are 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
Ensure this agreement includes a requirement to provide regulatory documentation within 20 day period if requested by the TGA.
Obtain Copies of Certification and Product Information
Ensure you obtain a copy of the manufacturer’s CE Marking certificate and basic device information.
This application will be dependent on device classification (according to the Therapeutic Goods (Medical Device) Regulations 2002 as amended) and will be submitted to the TGA. Part of this process includes establishing your organisation as a sponsor with the TGA. Begin to supply the medical device on the Australian market once an ARTG inclusion has been obtained.
Ensure your medical device’s promotional materials (including labelling and packaging) comply with the Therapeutic Goods Advertising Code (TGAC).
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.