ANSWERED ON THIS PAGE:
- How are medical devices classified in Australia?
- Must we register our device in Australia if it has CE Marking?
- Do foreign medical device manufacturers need in-country representation in Australia?
Before any medical device can be supplied in Australia, the device must be included in the Australian Register of Therapeutic Goods (ARTG), which is regulated by the Australian Therapeutic Goods Administration (TGA). Emergo, with its office in Sydney, can help you register your medical device or IVD with the TGA so you can start exporting your products into the Australian market.
Medical device registration routes in Australia
Companies that have already acquired market access in Europe will find the TGA process much easier because Australia recognizes CE Marking. In fact, 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.
Medical device classification in Australia
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 level. Australian classification rules are almost identical to the EU classification criteria and classification in Australia will generally reflect that of the EU.
Australia in-country representation for medical device companies
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.
Emergo can assist with Australia TGA medical device registration
With an experienced team in Australia, Emergo is fully equipped to 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:
- Assess the Australian TGA registration requirements for your device(s).
- Research the proper GMDN codes for your medical device(s).
- Conduct a Technical File review to ensure completeness.
- Assistance with compilation or review of clinical summary (a TGA requirement).
- Submit device applications to the TGA.
- Act as your Australian Sponsor to the TGA.
Emergo can help with all aspects of the TGA registration process. Your success in Australia is our goal.
Common questions regarding Australian TGA
Can we register our medical device in Australia if we do not have CE Marking?
Yes, but you must undergo a TGA Conformity Assessment, which is essentially equivalent to an EU Notified Body assessment to obtain CE marking certification. As such, it is recommended that manufacturers pursue CE marking prior to entering the Australian market so that certifications obtained and documentation prepared for the EU regulation can be leveraged towards Australian compliance.
How long does it take to complete the Australia registration process for medical devices?
TGA review timelines vary based on device classification. Download our Australia registration process chart for up-to-date review times by device classification.