FAQs
How are medical devices classified in Australia?
Medical devices in Australia are classified into four risk-based categories: Class I (low risk), Class IIa (low-medium risk), Class IIb (medium-high risk), and Class III (high risk). The classification depends on factors such as the device's intended use, duration of contact with the body, and potential impact on patient health or safety. Higher-risk classes typically require more rigorous regulatory scrutiny and documentation.
If our device has CE marking or FDA approval, do we still need to register it in Australia?
Yes, CE marking or FDA approval alone does not exempt a device from registration in Australia. All medical devices must be registered with the Therapeutic Goods Administration (TGA) before they can be supplied or marketed in the country. The TGA reviews compliance with Australian standards and safety requirements independently of other regulatory authorities.
Do foreign manufacturers need to have an in-country representative in Australia?
Yes. Foreign manufacturers who do not have a physical presence or legal entity in Australia must appoint an Australian Sponsor. This Sponsor acts as the local point of contact responsible for ensuring the device meets Australian regulations, handling TGA communications, and managing post-market obligations such as adverse event reporting and recalls.
When does an Australian medical device company need to appoint a local representative?
An Australian medical device company must appoint a local representative if it does not have a registered business address or legal entity in Australia. The Australian Sponsor serves as the official liaison with the TGA and is legally accountable for the device's compliance and regulatory standing in Australia.
What are the responsibilities of an Australian Sponsor?
The Australian Sponsor's key responsibilities include submitting and maintaining the device registration on the Australian Register of Therapeutic Goods (ARTG), conducting post-market surveillance to monitor device safety and performance, promptly reporting adverse events or product defects to the TGA, and displaying their contact details on the device labeling or instructions for use. They also coordinate any necessary product recalls or corrective actions.
What is the process for TGA conformity assessment?
For devices without CE marking, the TGA conducts a conformity assessment that evaluates the device's safety, effectiveness, and manufacturing quality. This involves a comprehensive review of technical documentation, clinical evidence, risk management files, and quality system certifications. The process ensures the device complies with relevant Australian regulatory requirements before approval.
How long does the registration process take?
The duration of the TGA registration process varies depending on the device class and complexity. Low-risk devices usually take a few weeks to register, while higher-risk devices that require detailed technical or clinical review may take several months. Timely and complete submission of documentation can help avoid delays.
What is the ARTG, and why is it important?
The Australian Register of Therapeutic Goods (ARTG) is an official database maintained by the TGA that lists all therapeutic goods, including medical devices, approved for supply in Australia. Registration on the ARTG is mandatory and serves as proof that a device has met safety and quality standards, allowing legal marketing and distribution. It also facilitates regulatory oversight and post-market monitoring to protect public health.