Australian Medical Device Sponsorship

Before someone can supply a medical device for sale in Australia they are required to make an application to include the device in the ARTG. The sponsor is the person or company responsible for the importation of medical devices into Australia, and/or the supply of medical devices in Australia, and/or the export of medical devices from Australia, as well as making application to the TGA to have their device included in the ARTG.

The sponsor must be a resident of Australia or be an incorporated body in Australia and conducting business in Australia where the representative of the company is residing in Australia.

If you are an overseas manufacturer of medical devices and you require Australian medical device registration, let Compliance Management Solutions act as your sponsor.

 

About CMS:

 

Compliance Management Solutions is a Melbourne based consultancy assisting organizations in obtaining and maintaining TGA/European (medicinal products/medical devices) | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 | AS/NZS 4801 (OH&S) | ISO 14001 (Environmental) certification and registration.