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Monitoring and compliance for implantable devices

Manage your implantable device after registration, including updates, reporting, and safety monitoring.

Once your implantable medical device is included in the Australian Register of Therapeutic Goods (ARTG) and supplied to the Australian market, you have ongoing regulatory responsibilities.  
 
You must:   

  • manage your device’s inclusion in the ARTG  

  • pay ongoing charges  

  • notify us of any changes or variations to your registered device  

  • monitor the safety and performance of the device and report any deterioration in performance  

  • maintain records and report adverse events that have caused or may cause injury or unintended harm.  

  • maintain appropriate Quality management systems (QMS) to support post-market surveillance  

 
We oversee monitoring and compliance activities to protect public health. 
 
Understanding your responsibilities and our role helps you stay compliant and keeps implantable devices safe and effective in Australia.  
  

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.

Compliance

Learn how we ensure compliance, including post-market reviews.

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