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Supply and distribution for personal protective equipment

Understand manufacturing standards for personal protective equipment (PPE) and how to legally supply, distribute, import, and export products. 

If you’re producing personal protective equipment (PPE) like masks, gloves or gowns for therapeutic use, you must meet regulatory requirements.   
  

Supply and distribution must protect product integrity during storage, handling and transport. If you import or export PPE, you must meet Australian regulations and maintain proper documentation.  
  

Understanding these requirements helps you meet your legal obligations and mange risks through the supply chain.  
  

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.  

Supply

Understand your obligations to manage the ongoing supply of products.

Import and export

Access requirements for import and export of therapeutic goods.

  • Export of medical devices

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    To export medical devices, including in-vitro diagnostic medical devices (IVDs) and other therapeutic goods (OTGs), you must meet requirements set out in the Australian therapeutic goods legislation.

  • Importing and supplying medical devices

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    Learn how medical devices are regulated in Australia, including ARTG requirements, importing and supply rules for health professionals, sponsor responsibilities, exemptions, and penalties for non‑compliance.
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