Monitoring and compliance for personalised medical devices

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

These requirements vary depending on whether your device is adaptable, patient-matched or custom-made. They may include adverse event reporting, recalls, and post-market surveillance.   
  

We oversee these activities to protect public health. Understanding your responsibilities and our role helps you stay compliant and ensures personalised medical devices remain safe and perform as intended.  
  

You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to personalised medical devices. You may also have to meet obligations that apply to all medical devices and all products.