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Supply and distribution for system and procedure packs

Understand manufacturing standards for therapeutic goods and how to legally supply, distribute, import, and export products for system and procedure packs.

Supply and distribution must protect product integrity during storage, handling, and transport. If you import or export packs, you must meet Australian regulations. This includes having clear responsibilities, validated transport and 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.
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