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An overview of disinfectants and sterilants

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

If you're planning to bring a disinfectant or sterilant product to the 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 labelling standards.  

 
Depending on the intended purpose, disinfectants and sterilants are either classified as medical devices or ‘other therapeutic goods’.  

 

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 OTG and all products.

General information

Learn about how products are regulated.

Definitions and classification

Understand how products are defined and classified.

  • What are 'therapeutic goods'?

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

Ingredients and scheduling

Get information about ingredient approvals and scheduling requirements.

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