After your system or procedure pack is on the market, you have ongoing responsibilities.
You must:
maintain your product’s inclusion in the Australian Register of Therapeutic Goods
pay ongoing regulatory charges
get approval for variations to your product
monitor your pack’s safety
report adverse events
cooperate with post-market surveillance activities.
We monitor products to ensure they continue to meet safety, quality, and performance standards.
Meeting these responsibilities helps protect patients, maintain compliance, and support confidence in your product.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to medical devices. You may also have to meet obligations that apply to all medical devices and all products.
Monitoring and reporting
Find sponsor obligations for ongoing monitoring and reporting.
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User guideA user guide for sponsors on how to fill in a device incident report.
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PageFind out what happens after you submit a report and actions we can take.
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PageFind out how to manage a medical device supply disruption or shortage if you're a sponsor, consumer, healthcare facility or professional.
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PageFind out about our process for conducting post-market reviews of medical devices.
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GuidanceGuidance on reporting adverse events for sponsors of medical devices.
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GuidanceGuidance for sponsors of certain medical devices who are required to submit annual reports.
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GuidanceGuidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.
Compliance
Learn how we ensure compliance, including post-market reviews.
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PageFollowing a review by the TGA, medical device entries (including IVDs) can be cancelled from the Australian Register of Therapeutic Goods.
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PageThe cancellation of a medical device can be limited by the Secretary to only some of the medical devices in such an entry.
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PageFrom 16 September 2021, suspended medical devices will not be visible in the ARTG database on the TGA website.