ANSWERED ON THIS PAGE:
- How are medical devices classified in Australia?
- Must we register our device in Australia if it has CE marking or FDA clearance?
- 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 Australian TGA regulatory approval process much easier because the TGA recognizes other comparable regulatory agency’s market authorizations (including the EU CE marking certificate ). In fact, most foreign companies seeking market access in Australia already have CE marking or FDA clearance. However, even if the medical or IVD device has authorization in a reference market, 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. Note that there are certain exceptions, and differences in classification may limit the ability to leverage their EU CE marking certificate or trigger a mandatory application audit of the ARTG application. Thus, classification should always be confirmed according to Australian classification rules. Emergo can assist with confirming the classification of your medical and IVD devices.
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 approval in a reference market prior to entering the Australian market so that they can leverage certifications obtained and documentation prepared toward Australian compliance. Manufacturers may leverage certification/clearance/ approval/authorization from several other comparable overseas regulators/bodies, such as the U.S. Food and Drug Administration (FDA), Health Canada, Medical Device Single Audit Program (MDSAP) Auditing Organizations (AOs), and the Health Sciences Authority in Singapore.
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. Contact our experienced Australian regulatory consultants for medical device market access at Emergo for help evaluating the Australian medical device regulatory framework as it applies to your device(s).