Before any medical device can be supplied in Australia, the device must be included in the Australian Register of Therapeutic Goods (ARTG), regulated by the Australian Therapeutic Goods Administration (TGA).
The TGA uses a four-tiered classification system based on risk to the human body, with ascending risk assigned to Classes I (including sterile and measuring), IIa, IIb, and III, respectively. Like most systems, regulatory control increases with increasing risk levels. Australian classification rules are almost identical to the EU classification criteria, and classification in Australia will generally reflect that of the EU.
Companies already acquired market access in Europe will find the TGA process much easier because Australia recognizes CE Marking. Most foreign companies seeking market access in Australia already have CE Marking. However, even if the medical device or IVD has CE Marking, it must still be registered with the TGA and receive an ARTG listing number. There is also a mandatory audit for certain device classifications.
Companies without an established place of business in Australia must appoint an in-country representative, known as an Australian Sponsor. The Australian Sponsor is responsible for device registration (ARTG listing) and post-market activities, such as adverse incident reporting and recalls. The Australia Sponsor’s name and contact information must appear on the device and device label. Emergo can provide Australia Sponsor services from our office in Sydney.
With an experienced international team, Kaiyan can help you access Australia’s thriving medical device market. Our experienced consultants have experience with conformity assessments for a broad range of device types. Here’s how we can help:
