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An overview of personalised medical devices

Information about how therapeutic goods move through the regulatory lifecycle from early product development to post-market for personalised medical devices.

If you're planning to bring a personalised medical device to market in Australia, this is your starting point.   
  

You need to understand how we regulate these products and your obligations at each stage.  
  

This includes:   

  • choosing the correct category (adaptable, patient-matched or custom-made)

  • preparing evidence, and   

  • meeting safety, quality, and performance requirements.  

 
By being well prepared, you can avoid regulatory delays.  

 
Start by learning your responsibilities and planning each stage of your product’s lifecycle.  
  

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.

General information

Learn about how products are regulated.

Definitions and classification

Understand how products are defined and classified.

Legislation, Acts and Orders

Review the laws and legal orders that regulate therapeutic goods.

Standards and requirements

Understand product obligations for safety, quality and efficacy.

Product types