Therapeutic Goods Administration (TGA) is responsible for the registration of medical device in Australia.
The main regulations in Australia are "Therapeutic Goods Act 1989", "Therapeutic Goods (Medical Devices)
Regulations 2002", etc. Foreign manufacturers need to have a local authorized representative (Australian Sponsor)
in Australia to handle registration-related issues..
In Australia, medical devices are classified based on their risk level to human . Non-IVD medical device products
are divided into four classes according to risk from low to high: Class I (including Class Is devices that are sterile,
and Class Im devices with measurement functions), Class IIa, Class IIb and Class III; while IVD medical device
products are divided into Class 1, Class 2, Class 3 and Class 4 according to the risk from low to high. Similar as
regulatory authorities wordwide, the level of regulatory control by authorities increases with the level of risk.
The TGA's classification regulations are almost identical to the EU's classification standards, so Australia's medical
device classification usually reflects the EU's classification.
Depending on the risk level and specific circumstances of the medical device, the cost and time required for registration
are also different.
Fees range from a few hundred dollars for the lowest risk levels, to tens of thousands of dollars for higher risks. In
addition, there are some additional costs that may be incurred, such as if the manufacturer seeking for “priority
Lower-risk products require fewer documents and the registration process only takes a few weeks. For example,
Class I non-sterile and non-measuring medical device only requires simple documents such as a declaration of
conformity (DOC). However, higher-risk medical device may require mandatory audit.
The TGA recognizes existing approvals from certain overseas regulatory authorities, which can shorten the overall
review time. For example, products registered in the European Union, the United States, Canada, Japan, Singapore,
etc., or products within the scope of Medical Device Single Audit Program (MDSAP) certification have a faster review
path than uncertified products. It should be noted that even if the medical device has a registration certificate from
the above mentioned authorities, it still needs to be registered in the TGA's Australian Register of Therapeutic Goods
(ARTG) system. However, if the product does not have available overseas regulatory approval, a full TGA compliance
review process must be initiated, which may take 1-2 years, depending on the risk level of the device and the
completeness of the documentation provided.
Osmunda’s global team can assist you in completing Australian product registration and provide you with local
agency services in Australia. If you want to know more about the registration of your product in Australia, please
feel free to contact us.