While the consultation is open you can make a submission at our consultation hub.
We will review your submissions and publish them, along with our response, on the same consultation page.
About this consultation
The TGA is seeking feedback on proposed changes to the regulation of exempt medical devices and exempt Other Therapeutic Goods (OTGs).
The TGA is Australia's government authority responsible for evaluating, assessing, and monitoring products that are defined as therapeutic goods including medicines, medical devices and biologicals to help Australians stay healthy and safe.
Products that meet the legislative definition of a therapeutic good under the Therapeutic Goods Act 1989 (the Act) are regulated by the TGA and generally need to seek pre-market approval and be included in the Australian Register of Therapeutic Goods (ARTG) before they can be imported, exported or supplied. If the therapeutic good is a medical device, an application for inclusion in the ARTG must be supported by manufacturer’s evidence. Manufacturer’s evidence consists of documents, including certification from independent bodies, demonstrating that the medical device is safe and fit for its intended purpose.
In some circumstances it is not practical to require pre-market approval by the TGA and/or ARTG inclusion for a therapeutic good or there are existing risk mitigating strategies in place. Exemption allows these kinds of products to be continually supplied without seeking pre-market approval by the TGA or inclusion in the ARTG.
While exempt products are not required to be included in the ARTG, they are not excluded from regulation and must generally still meet all regulatory obligations under the Therapeutic Goods Act 1989.
Recent work undertaken to refine the regulation of medical devices in Australia has led to an increase in the use of exemptions to remove barriers to supply where appropriate. These changes have highlighted regulatory issues and risks associated with the use of exemptions. Feedback from external stakeholders indicates in many cases the current arrangements for exempt medical devices and OTGs are not fit-for-purpose, and a review is required to ensure appropriate regulation for these kinds of products.
Based on feedback and information from stakeholders, we have identified three key proposals for change:
- Require notification of supply
- Publish information about supply
- Provision of information and samples
This consultation paper is intended to seek feedback on the proposed changes and their application to existing exemptions and will inform the policy decisions that will be made by the Australian Government.
All recent consultations can be found on our TGA Consultation hub.