The Therapeutic Goods Administration (TGA) is inviting industry feedback on proposed changes to the regulation of exempt medical devices and Other Therapeutic Goods (OTGs).
The initiative follows recent efforts to streamline medical device regulation in Australia, which have increased the use of exemptions to facilitate supply.
The TGA highlighted regulatory issues and risks linked to exemptions, noting that feedback from stakeholders suggests the current arrangements are often unsuitable. To address these concerns, the TGA proposes three key changes: requiring notification of supply, publishing supply information and providing samples and information.
Why exemptions exist
Under the Therapeutic Goods Act 1989, therapeutic goods must generally receive pre-market approval and be listed in the Australian Register of Therapeutic Goods (ARTG). However, exemptions exist for products that do not require pre-market approval due to existing risk mitigation strategies.
Exemptions may apply when suitable regulatory frameworks manage product risks, when devices are not freely available or during transitional periods for new regulatory requirements. Current issues with exemptions include a lack of information about exempt products, rising regulatory costs, low awareness and compliance and difficulty in identifying compliant products.
The TGA noted that regulatory costs for exempt products are increasing, and without cost-recovery measures, pressure on resources will continue to rise. Additionally, stakeholders have called for greater transparency and accountability for exempt products.
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, an inability to determine the supplier of exempt products is a barrier to post-market activities, delaying responses to adverse events and recall activities. These delays represent a risk to consumer/patient health and safety.
Expenditure on regulating exempt devices and exempt OTGs is continuing to rise as the number of exemptions increases. 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.
In a number of instances, the sponsors of exempt products have assumed “exempt” means “excluded” from all regulation by the TGA. Consequently, there are low rates of awareness 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 for increased 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 period will close on June 9.
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