Are You Ready for a TGA Post-Market Review? Post-Market Surveillance (PMS) Obligations for Australian Sponsors

Inclusion of a medical device in the Australian Register of Therapeutic Goods (ARTG) is not the end of an Australian sponsor’s regulatory responsibilities.

Once a medical device is supplied in Australia, sponsors have ongoing post-market obligations to support the continued safety and performance of the device throughout its lifecycle.

The Therapeutic Goods Administration (TGA) actively monitors medical devices after they enter the Australian market. A medical device may be selected for post-market review at any time to assess whether it continues to be safe, performs as intended and whether the sponsor continues to meet its regulatory obligations.

For Australian sponsors, having effective PMS systems and appropriate arrangements with their manufacturers is therefore an important part of maintaining ongoing regulatory compliance.

The importance of these obligations has recently been brought into focus by a new TGA consultation proposing greater transparency around medical device post-market reviews and investigations.

What can trigger a TGA post-market review?

A TGA post-market review or investigation may arise from a range of information obtained after a device has entered the market.

This may include adverse event reports, complaints, recalls or other market actions, emerging safety signals, information obtained from overseas regulators, published literature, changes in the known benefit-risk profile of a device, or other information relating to its safety, quality, performance or use.

Importantly, the absence of a serious adverse event does not necessarily mean that post-market information does not require further consideration. Trends in complaints, device deficiencies or other data may identify an emerging issue before it results in serious harm.

What information may the TGA request?

The information required will depend on the nature of the review and the device concerned.

Sponsors may be required to obtain and provide information from the manufacturer relating to matters such as:

• Complaint and adverse event data;
• Complaint investigations and corrective actions;
• Worldwide sales or distribution data;
• PMS reports and trend analyses;
• Periodic Safety Update Reports (PSURs), where applicable;
• Risk management documentation;
• Clinical evidence and clinical evaluation documentation;
• Recalls, corrective actions or other regulatory actions undertaken in Australia or overseas; and
• Information concerning similar regulatory investigations or actions in other jurisdictions.

The ability to retrieve and provide this information promptly is particularly important for Australian sponsors where the manufacturer is located overseas.

PMS should be an active process

Effective PMS involves more than collecting complaints and adverse event reports.

Post-market information should be actively reviewed and analysed to identify trends, emerging risks and potential changes to the benefit-risk profile of the device.

Where relevant, post-market findings should also feed back into other elements of the manufacturer’s quality management system and technical documentation, including risk management and clinical evaluation activities.

A well-designed PMS system provides a structured approach for collecting, reviewing and responding to post-market information throughout the lifecycle of a device. It should also support the sponsor and manufacturer in identifying when further investigation, corrective action or regulatory reporting may be required.

What is the role of the Australian sponsor?

Australian sponsors have important responsibilities once a medical device has been included in the ARTG.

Sponsors should have appropriate processes and arrangements in place with their manufacturers to ensure that relevant post-market information can be obtained and communicated when required.

This is particularly important where the manufacturer is located overseas. Australian reporting timeframes and TGA requests may require the sponsor to obtain information from the manufacturer within relatively short periods.

Clear communication pathways and defined responsibilities between the manufacturer and sponsor can make a significant difference when responding to a safety issue or regulatory request.

Sponsors should also ensure they understand their Australian vigilance and reporting obligations rather than relying solely on the manufacturer’s procedures or reporting requirements in other jurisdictions.

Is your PMS ready for TGA scrutiny?

A TGA post-market review can require a sponsor to obtain and provide significant information within specified timeframes.

For sponsors without a well-established PMS system, a regulatory request may expose gaps in procedures, complaint and vigilance processes, manufacturer communication arrangements or the availability of current post-market documentation.

Even where a PMS system is already established, it is important to periodically assess whether it remains appropriate for the devices being sponsored and continues to meet applicable Australian regulatory requirements.

Taking a proactive approach allows potential gaps to be identified and addressed before a device becomes subject to TGA scrutiny.

Current TGA consultation: greater transparency of post-market reviews

The TGA is currently seeking feedback on a proposal to improve the sharing of information about the safety, quality and performance of medical devices.

The proposed changes are intended to allow more information to be provided to the public following medical device post-market reviews or investigations, particularly where findings relate to the safety, quality, performance or use of a device.

The TGA is specifically seeking feedback on:

• Whether information should be shared about medical devices involved in a post-market review or investigation; and
• What types of information should be shared when a post-market review or investigation is being undertaken.

The proposed changes seek to expand the circumstances in which information can lawfully be released under section 61 of the Therapeutic Goods Act 1989.

For sponsors and manufacturers, the consultation is a timely reminder of the increasing focus on transparency around post-market regulatory activities and the importance of maintaining robust post-market systems and records.

The consultation opened on 13 August 2026 and closes on 2 October 2026. Sponsors, manufacturers and other interested stakeholders can review the proposal and provide feedback directly to the TGA through its consultation hub.

Read more and provide feedback: TGA – Consultation on sharing more information about medical devices

How KD&A can assist

KD&A assists Australian sponsors and medical device manufacturers with the development, implementation and review of PMS systems to support ongoing compliance with Australian regulatory requirements.

For sponsors who do not currently have a comprehensive PMS system in place, KD&A can assist with developing the necessary procedures, processes and documentation to establish an appropriate framework for ongoing post-market activities.

For sponsors with an existing PMS system, KD&A can undertake a PMS system review to assess current procedures, records and manufacturer arrangements, identify potential gaps and recommend actions to strengthen regulatory compliance and preparedness for TGA scrutiny.

Our PMS regulatory support can also include:

• Complaint and vigilance procedures;

• PMS Plans and Reports;
• Periodic Safety Update Reports (PSURs);
• Adverse event and regulatory reporting;
• Risk management and clinical evaluation updates arising from PMS information; and
• Assistance responding to TGA PMS reviews and investigations.

Whether you are establishing a PMS system for the first time, reviewing an existing system or responding to a TGA PMS request, contact KD&A to discuss how we can support your PMS regulatory obligations.