Application and market authorisation for personal protective equipment

To legally supply personal protective equipment (PPE) that is a medical device in Australia, you must apply to include it in the Australian Register of Therapeutic Goods (ARTG).   
  

If your PPE claims to prevent disease transmission between people, resist bodily fluids, or has therapeutic use, it is regulated as a medical device.   
  

Submit your application through the Business Services portal, provide evidence of safety and performance, and pay the required fees.   
  

This process confirms your product meets our standards and is approved for supply.  
  

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.