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Monitoring and compliance for in vitro diagnostic devices

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

After your in vitro diagnostic (IVD) device is on the market, you have ongoing responsibilities to meet regulatory requirements.  
 
You must:   

  • manage your device’s inclusion in the Australian Register of Therapeutic Goods  

  • pay regulatory charges  

  • notify us of any changes or variations to your product  

  • monitor safety and report issues  

  • support post-market surveillance

 
We oversee monitoring and compliance activities to protect public health. Understanding your responsibilities helps you stay compliant and ensures IVDs remain safe in Australia.  
  

You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to IVDs. 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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