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Monitoring and compliance for personal protective equipment

Manage your personal protective equipment (PPE) product after registration, including updates, reporting, and safety monitoring.

After your personal protective equipment (PPE) 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 product variations    

  • monitor your PPE’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.

Compliance

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

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