The Therapeutic Goods Administration (TGA) is responsible for the registration of medical devices in Australia. The main regulations in Australia governing the sale of medical devices are the “Therapeutic Goods Act 1989” and the “Therapeutic Goods (Medical Devices) Regulations 2002”. 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 humans. Medical device products (excluding IVDs) are divided into four classes according to risk from low to high: Class I, Class Is sterile devices, 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 level to both the public and individual from low to high. Similar to other worldwide regulatory authorities, the level of regulatory control by the TGA increases with the level of risk.  The TGA's classification regulations are similarly aligned to the EU's classification standards, therefore Australia's medical device classifications usually reflect those in the EU.

Depending on the risk level and various specifications of the medical device, the cost and time required for the registration process are also different.

Application fees typically range from a few hundred Australian dollars (AUD) for the lowest risk level products i.e. Class I products, to over one thousand Australian dollars for the highest risk level products i.e. Class II and III products. In addition, there is an annual charge for the inclusion of the product to the ARTG which ranges from approximately one hundred AUD to over one thousand AUD.  If the manufacturer is seeking “priority applicant determination”, further additional application fees apply to this process amounting to over ten thousand AUD.

Lower-risk products require less documentation to be submitted and the registration process should only take a maximum of a few weeks. For example, a Class I non-sterile and non-measuring medical device only requires basic documentation such as a declaration of conformity (DOC). However, the registration of higher-risk medical devices may require mandatory audits and the review process will take a few months for products with existing overseas certification to over 12 months for products which require local conformity assessment from the TGA.

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. have a faster review path before registration compared to products products without external certification. 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). However, if the product does not have available overseas regulatory approval, a full TGA conformity assessment must be initiated, which can take up to a statutory maximum of 255 business days to complete, depending on the risk level of the device and the quality and completeness of the documentation provided.

Osmunda’s global team can assist you in completing your Australian product registration and provide you with local agency services in Australia. If you would like to know more about the registration of your product in Australia, please feel free to contact us.