Site notifications

Sub menu

 

 

An overview of software and artificial intelligence

Information about how therapeutic goods move through the regulatory lifecycle from early product development to post-market for software and artificial intelligence (AI).

If you're planning to supply a software medical device in Australia, including those using artificial intelligence, this is your starting point.   
  

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

  • determining if your product meets the medical device definition  

  • determining if an exclusion or exemption applies   

  • selecting the correct classification  

  • compiling evidence of safety and performance.   

 
Being well prepared helps ensure your product meets Australian requirements and avoids regulatory delays.   

 
Start by learning your responsibilities and the regulatory requirements that apply to your device.  
  

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