Manufacturing for medical devices

Producing medical devices requires meeting regulatory requirements to ensure quality, safety and performance.   
  

Manufacturers take full responsibility for the design and production of a medical device, whether they make the device themselves or subcontract some of these activities.  
  

Some devices must be manufactured under a certified Quality Management System. 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 products.