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An overview of other therapeutic goods

Information about how other therapeutic goods move through the regulatory lifecycle from early product development to post-market.

If you're planning to bring an ‘other therapeutic good’ to market in Australia, this is your starting point.   
  

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

  • selecting the correct regulatory pathway  

  • preparing evidence  

  • complying with safety, quality and performance standards.  

 
Being well prepared helps ensures your product meets Australian requirements and avoids delays getting your product to market.   
  

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 other therapeutic goods (OTG). 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.

  • Is my product a therapeutic good?

    Decision tree
    Use this decision tree to work out if the product you want to sell or supply in Australia is a therapeutic good.

  • What are 'therapeutic goods'?

    Page
    Therapeutic goods can comprise a broad range of things, such as bandages, pregnancy testing kits, herbal remedies, tissue grafts and paracetamol.

Legislation, Acts and Orders

Review the laws and legal orders that regulate therapeutic goods.

Product types