Australia being an IMDRF founding member has a harmonized regulations in place governed by Therapeutic Goods Administration (TGA). The TGA regulations for medical devices somewhat resemble the European regulations and in fact, Australia has an abridged process of the devices those hold EU or US regulatory clearances.

Medical Device Industry is one of the most dynamic and advanced manufacturing sectors in Australia and has sustained its potential to offer substantial health gains and high-level employment opportunities and contribute to grow Australia’s export of technology. According to Worldwide Medical Device Factbook, Australia is ranked at 13th in the world in terms of total market value.

Classification

Determination of the medical device classification is the first and foremost step for the medical device manufacturers. Doing it right is very important. The class to which your device is assigned determines, among other things, the conformity assessment pathway required and the PMS requirements.

ARTG Listing

ARTG listing is the important task for sending your devices to Australia. Medical devices (Therapeutic goods) entered in the Australian Register of Therapeutic Goods (ARTG) can only be lawfully supplied in Australia. Information held in the ARTG includes ‘product name and formulation details’  and ‘sponsor (company) and manufacturer details’.

Conformity Assessment

Conformity assessment is the systematic and ongoing examination of evidence and procedures to ensure that a medical device (including IVD medical devices) complies with the essential principles. Manufacturers of all medical devices (including IVD medical devices) manufactured and/or supplied in Australia should ensure that they have: 1) appropriate conformity assessment procedures in place for the device; and 2) appropriate documentation demonstrating compliance of the device with the essential principles.

Evidence that a device has undergone an appropriate conformity assessment procedure must be held before a device can be included in the Australian Register of Therapeutic Goods (ARTG).