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Supply and distribution for medical devices

Find requirements for the ongoing supply, import, export, storage and handling of medical devices.

Producing and supplying medical devices requires meeting regulatory requirements to ensure quality, safety and performance. 
   

Some devices must be manufactured under a certified Quality Management System. They must also comply with the Essential Principles to ensure safety and performance.   
  

Effective supply and distribution processes help keep devices available and safe for users. If you import or export medical devices, you must comply with Australian regulations.   
  

Understanding these rules helps you meet your legal obligations and manage risks throughout the supply chain for medical devices in Australia.  
 

You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information about medical devices, and specific types of medical devices. You may also have to meet obligations that apply to 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.

  • Applying for an export certification for medical devices

    Guidance
    This guidance is to assist you to apply for a Certificate of Free Sale or an Export Certificate for medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs).

  • Export

    Page
    Information on the legal requirements for exporting medicines, medical devices and human substances from Australia.

  • Export of medical devices

    Page
    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.

  • Import

    Page
    Information on the legal requirements for importing therapeutic goods into Australia, including 'unapproved' therapeutic goods and controlled substances.

  • Importing therapeutic goods

    Page
    Legal requirements for importing therapeutic goods into Australia, including unapproved therapeutic goods and controlled substances.
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