Site notifications

Sub menu

 

 

Supply and distribution for personalised medical devices

Understand how to legally supply, distribute, import, and export personalised medical devices. 

You are responsible for effective supply and distribution processes to keep devices safe and available.   
  

You need to manage risks across the supply chain and comply with Australian regulations, including for import and export.  

 

You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to personalised 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

    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.

  • Importing and supplying medical devices

    Page
    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.
Product types