Manufacturing for implantable devices

Producing and supplying implantable devices requires meeting regulatory standards to ensure safety and quality.   
  

Devices must be manufactured under a certified Quality Management System (QMS). They must also comply with the Essential Principles to ensure safety and performance.  
  

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.