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Monitoring and compliance for medical devices

Manage your product after registration, including updates, reporting, and safety monitoring for medical devices. 

After your medical device is on the market, you have ongoing responsibilities to meet regulatory requirements.   
  

You must:   

  • pay ongoing charges  

  • manage your device’s registration  

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

  • monitor safety  

  • report issues  

  • support post-market surveillance.

 
We monitor compliance to protect public health and take action if risks arise.  

 
Meeting these post market obligations helps your device remain safe, effective and compliant with Australian regulations.  
  

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 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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