The Therapeutic Goods Administration (TGA) is seeking industry feedback on the proposed changes to the regulation of exempt medical devices and exempt Other Therapeutic Goods (OTGs).
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, according to the TGA.
The TGA says these changes have highlighted regulatory issues and risks associated with the use of exemptions, and feedback from external stakeholders indicates a review is required to ensure appropriate regulation for these kinds of products as, in many cases, the current arrangements for exempt medical devices and OTGs are not fit-for-purpose.
The TGA has identified three key proposals for change: require notification of supply; publish information about supply; and provision of information and samples.
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.
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.
An exemption may be given to devices and OTGs when: there are already suitable frameworks for the regulation of a product in place to manage risks associated with the manufacture of a product; when a device is not freely available on the market; and, in instances where a device is subject to a transition period due to the introduction of new regulatory requirements, such as patient-matched medical devices that were previously custom-made and are now transitioning to inclusion in the ARTG.
The TGA has outlined the following issues with the current use of exemptions for medical devices and OTGs:
- Lack of information about exempt products. Where sponsors are not required to notify the TGA about the manufacture and/or supply of these kinds of products, there is a barrier to determining the supplier of exempt products and therefore to some post-market activities, including timely responses to adverse events and recall activities.
- Expenditure on regulating exempt devices and exempt OTGs is continuing to rise as the number of exemptions increase. Without cost-recovery measures for the regulation of a widening scope of sponsors and products, pressure on available resources for post-market and reform work will continue to rise.
- There are low rates of awareness of and compliance with regulatory requirements associated with some exempt products. Lack of available information identifying these sponsors further limits TGA’s ability to contact them for the purposes of education and communication.
- Identification of exempt devices and OTGs that are complying with current regulatory requirements is difficult for stakeholders including members of the public and other government providers who use TGA approval as a basis for reimbursement. Healthcare providers, members of industry and consumers have all expressed a desire forincreased transparency and accountability of exempt products.
- Recent changes to the medical device regulatory framework mean supply of medical devices from smaller manufacturers, particularly in healthcare sectors, is likely to become constrained in the coming years as the cost of including devices in the ARTG becomes prohibitive. The use of exemptions to provide a pathway for the manufacture and supply of devices in these sectors is therefore likely to increase, compounding the existing issues.
The consultation will close on Sunday 9 June 2024.