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An overview of medical devices

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

If you're planning to bring a 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:  

  • determining whether your product meets the definition of a medical device  

  • determining whether any exclusions or exemptions apply  

  • choosing the correct classification  

  • preparing evidence  

  • meeting product standards

 
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 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