Application and market authorisation for implantable devices

To legally supply an implantable device in Australia, you must apply to include it in the Australian Register of Therapeutic Goods (ARTG). You will need to submit your application through our Business Services portal. 
 

We will evaluate your application to ensure your implantable device meets safety, performance and quality standards. Application and evaluation fees apply as part of this process. 
 

This stage ensures your implantable device complies with regulatory requirements and is authorised for supply in the Australian market. 
 

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.