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

Closed 14 Jun 2024

Opened 15 Apr 2024

Contact

1800 14

devices@tga.gov.au

Feedback updated 15 Jan 2025

We asked

The Therapeutic Goods Administration (TGA) undertook a public consultation related to the regulation of exempt medical devices and exempt Other Therapeutic Goods (OTGs). The primary objective of the proposed changes were to improve the transparency, identification and awareness of products in these categories; thereby supporting faster action if safety concerns were identified.

There is widespread misunderstanding and confusion about what regulatory requirements manufacturers and sponsors need to meet if they supply exempt medical devices. Sponsors of these categories of goods are still subject to, and must meet, relevant regulatory obligations and they are subject to oversight by the TGA.

The consultation sought feedback from stakeholders on three (3) proposals to improve the regulation of exempt medical devices and exempt OTGs:

  1. Require notification of supply to the TGA
  2. Publish information about supply on the TGA website
  3. Provision of information and samples of products to the TGA.

You said

Thirty-eight (38) responses were submitted by a range of stakeholders, including manufacturers, sponsors, healthcare providers from the fields of dentistry and allied health, hospitals, consumers, regulatory affairs consultants, and state and territory governments. 

Proposal 1: Require notification of supply to the TGA
We asked stakeholders for feedback on the proposal to require notification of supply from sponsors of certain exempt medical devices and exempt OTGs as per Appendix A of the consultation paper.

The responses were mixed, with half supporting this proposal and the other half not supportive of any change. Respondents who agreed with this proposal suggested that it would improve the TGA’s oversight and monitoring of these products. Some stakeholders clarified they would be supportive of this proposal if multiple products could be submitted under one notification. Those that disagreed suggested that notifications of supply would increase costs and regulatory burden without increasing patient safety. Industry and healthcare providers said the current regulatory framework is sufficient, without introducing notifications of supply.

We also asked stakeholders which exempt devices and exempt OTGs should require notification of supply and what information should be provided in these notifications. There was broad support to require notifications for exempt OTGs, exempt clinical decision support software, and exempt medical devices manufactured by healthcare providers. 

Most stakeholders agreed that notifications of supply should include contact information about the sponsor (e.g. name and postal address) and details about the exempt devices and exempt OTGs (e.g. product description or intended purpose, kind of device or OTG). 

Proposal 2: Publish information about products being supplied
We asked stakeholders for feedback on the proposal to publish information about the notifications of supply of exempt devices and exempt OTGs on the TGA website. 

Most respondents agreed with the proposal to publish this information. Stakeholders supporting this proposal advised that publishing this information would support both patients and healthcare providers to make informed decisions about using exempt devices and exempt OTGs. They also suggested that publishing this information would increase transparency and accountability for manufacturers and sponsors. 

Stakeholders who disagreed with this proposal advised that consumers should always be encouraged to contact the healthcare provider in the first instance for any issues with the product. They also noted that the exempt products they supply do not have sufficient risk associated with them to necessitate the requirement for notifications.

It was also noted that, for OTGs, sponsor contact information is already on packaging, however, this does not provide clarity for the TGA if there are any problems or issues with the product – ie: the TGA is not able to contact the sponsor/manufacturer.

Stakeholders also indicated that information about exemptions should not be made publicly available where there is a risk of breaching privacy or confidentiality. (Note that “supply” in this consultation refers to an organisation that distributes a product – it does not refer to each individual instance of supplying a product to a particular consumer or purchaser). 

Proposal 3: Provision of information and samples to TGA 
We asked stakeholders for feedback on proposals to require sponsors to provide information about exempt devices and exempt OTGs and product samples to the TGA upon request. 

Most respondents agreed that sponsors should be required to give additional information and provide samples to the TGA upon request. Stakeholders said information requests should be limited to requests for information that sponsors or manufacturers are ordinarily required to have available to meet their regulatory requirements (eg: evidence of compliance with Essential Principles, logs of adverse events etc). Some stakeholders noted that the cost of providing product samples to the TGA for exempt personalised medical devices may be prohibitive and would not be suitable for exempt devices imported for personal use.

Further feedback
Stakeholders requested increased clarity and details on how these proposals might be implemented by the TGA. They asked for more details on the specific issues the TGA has experienced with regulating exempt medical devices and exempt OTGs. Several stakeholders asked that the TGA conduct educational activities and improve website guidance to increase sponsor awareness and compliance with the TGA’s regulatory requirements for exempt devices and exempt OTGs.

We did

As suggested by some stakeholders through consultation feedback, the TGA conducted targeted workshops to further discuss topics related to the regulation of exempt devices and OTGs mentioned in this consultation paper. 

Targeted stakeholder workshop
The TGA organised a targeted stakeholder workshop in October 2024 to discuss outcomes of the public consultation, provide and seek clarification on some of the issues raised and seek further feedback. Thirty-nine (39) stakeholders attended including sponsors, industry peak bodies, dental and allied health professionals and regulatory affairs consultants. Most attendees had provided responses to the public consultation.

Feedback from the workshops showed that most workshop participants disagreed with the TGA collecting and publishing information on exempt devices and OTGs (proposals 1 and 2). Slightly more than half of the workshop participants disagreed with providing information and samples to the TGA upon request (proposal 3).

We asked stakeholders for feedback on the following new proposals for improving regulation of exempt devices and OTGs:

  • Educational outreach activities to raise sponsor awareness of their regulatory obligations.
  • Changing terminology for ‘exempt’ devices and OTGs that have notification requirements to improve regulatory clarity for stakeholders.
  • Requiring adverse event reporting for exempt devices and OTGs.
  • Amending mandatory periodic reporting requirements for exempt devices and OTGs to reduce regulatory burden.
  • Using the Medical Devices Vigilance Program (MDVP) for certain exempt devices and OTGs.
  • Investigating compliance monitoring and an associated resourcing fee model.

Stakeholders generally agreed with these new proposals, with some exceptions.

When asked if stakeholders agreed with mandatory periodic adverse event reporting for patient safety, they were generally supportive. However, when asked if they supported mandatory periodic adverse event reporting for their specific sector, they were less supportive. Slightly more respondents supported mandatory periodic adverse event reporting for exempt dental / orthopaedic devices made by healthcare professionals and exempt disinfectants, compared to custom made medical devices, low volume patient matched medical devices, exempt Clinical Decision Support Systems, tampons and menstrual cups. 

When asked if stakeholders supported using the Medical Device Vigilance Program (MDVP) for certain exempt devices and OTGs, some stakeholders were unfamiliar with what the MDVP was, whilst others were uncertain as to how the MDVP would be applied to their exempt product. A stakeholder noted that the MDVP would be a useful tool in lieu of periodic reporting. 

The TGA also held targeted discussions with the Advisory Committee on Medical Devices, the Women’s Health Product Working Group and the Medical Devices Consumer Working Group. These groups generally support the proposals for improved traceability, transparency and accountability for exempt goods.

Based on the feedback provided, we will continue to convene further targeted consultations with stakeholders in 2025 about the proposals.

Published responses

View submitted responses where consent has been given to publish the response.

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:

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.

Audiences

  • Medical Devices & IVDs

Interests

  • Strategic Policy