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January 15, 2026
Approximately 5 minutes
Medical Device Post-Market Review Process in Australia
Medical Device Post-Market Review Process in Australia
1. Purpose of Post-Market Reviews
The Therapeutic Goods Administration (TGA) conducts post-market reviews to ensure that medical devices included in the Australian Register of Therapeutic Goods (ARTG) continue to meet the essential principles for safety and performance throughout their lifecycle. These reviews verify ongoing compliance, assess real-world safety and performance, and identify any need for regulatory action to protect public health. Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/medical-device-post-market-reviews/medical-device-post-market-review-process
Reviews complement pre-market assessment and help detect issues that may only become apparent after widespread use.
2. Triggers for Conducting a Review
A post-market review may be initiated by various triggers, including:
- Adverse event reports or trends identified through the IRIS system
- Emerging safety signals from Australian or international sources
- Routine monitoring or horizon scanning activities
- Specific concerns raised by stakeholders (healthcare professionals, patients, sponsors)
- Intelligence from international regulators or post-market surveillance data
The TGA prioritizes reviews based on risk to patients, prevalence of use, and potential public health impact. Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/medical-device-post-market-reviews/medical-device-post-market-review-process
3. Selection and Prioritization
Devices are selected for review based on a risk-based approach. Factors considered include:
- Risk classification of the device
- Volume of use in Australia
- History of adverse events or complaints
- Availability of alternative devices
- Alignment with current regulatory priorities
Once selected, the TGA notifies the sponsor/manufacturer of the review and its scope. Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/medical-device-post-market-reviews/medical-device-post-market-review-process
4. Review Process Steps
The structured review process typically includes:
- Notification — Sponsor receives formal notice outlining the review scope and requested information.
- Information Gathering — Sponsor provides requested documentation (technical files, risk management files, post-market surveillance data, clinical evidence, etc.).
- Assessment — TGA evaluates the submitted information against regulatory requirements, including essential principles and conformity assessment evidence.
- Analysis and Risk Evaluation — Identification of any non-compliance, safety concerns, or performance issues.
- Engagement — Sponsor may be given opportunity to respond to preliminary findings.
- Decision Making — Determination of regulatory outcomes. Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/medical-device-post-market-reviews/medical-device-post-market-review-process
Timelines vary depending on complexity and risk level.
5. Possible Outcomes
Outcomes may include:
- No action required (device meets requirements)
- Request for additional information or corrective actions
- Variation of ARTG entry conditions
- Suspension or cancellation of ARTG inclusion
- Recall or field safety corrective action
- Publication of safety communications or advisories
The TGA may also refer matters to other agencies if non-compliance involves manufacturing quality or advertising breaches. Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/medical-device-post-market-reviews/medical-device-post-market-review-process
6. Publication and Transparency
Finalised review outcomes are published on the TGA website, including:
- Summary of findings
- Regulatory actions taken
- Sponsor responses (where appropriate)
Publication enhances transparency and informs healthcare providers and the public about device safety status. Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/medical-device-post-market-reviews/medical-device-post-market-review-process
7. Sponsor Responsibilities During Review
Sponsors must:
- Respond fully and promptly to TGA requests
- Provide accurate and complete documentation
- Implement any required corrective actions
- Notify the TGA of changes affecting compliance
Failure to cooperate may result in escalated regulatory action. Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/medical-device-post-market-reviews/medical-device-post-market-review-process
The post-market review process is a key component of the TGA's lifecycle approach to medical device regulation, ensuring ongoing safety and performance in the Australian healthcare system.
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