Proposed changes to the regulation of exempt medical devices and exempt Other Therapeutic Goods

Overview

The TGA is Australia's government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods. The TGA regulates 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. In the case of devices and OTGs, circumstances where an exemption may be given include:

• Where there are already suitable frameworks for the regulation of a product in place to manage risks associated with the manufacture of a product, such as where a device is manufactured as a component of clinical practice.
• Where a device is not freely available on the market, such as for use in a clinical trial or for use by a visiting sporting team.
• 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.

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, including:

• Ensuring the device(s) meets all relevant Essential Principles, including supplying the devices with adequate labelling and Instructions For Use.
• Applying appropriate conformity assessment procedures to the device at all times.
• Ensuring advertising complies with the advertising requirements.
• Reporting adverse events.

The TGA maintains a number of relevant regulatory powers with respect to exempt products including the capacity to:

• Undertake post-market review to ensure they meet all relevant regulatory requirements.
• Require exempt devices and OTGs to comply with the Advertising Code.
• Conduct a recall activity in relation to the products, including issuing a hazard alert if there is a problem with the product.

Exemptions can only be granted in circumstances where certain conditions are met. Examples include:

• Where a notification of manufacture/supply has been provided to the TGA (eg: custom-made medical devices).
• Where devices are supplied in low volumes (eg: patient-matched medical devices).
• Where a device is only for use on an individual or an immediate family member (eg: personal importation).
• Clinical decision support software that meet specific criteria.

Why your views matter

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.

Issues with the current use of exemptions for medical devices and OTGs include:

• 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.

Based on feedback and information from stakeholders, we have identified three key proposals for change:

1. Require notification of supply
2. Publish information about supply
3. Provision of information and samples

This consultation paper is intended to seek feedback on the proposed changes and their application to existing exemptions.