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Supply and distribution for implantable devices

Understand manufacturing standards for implantable devices and how to legally supply, distribute, import, and export products.

Producing and supplying implantable devices requires meeting regulatory standards to ensure safety and quality. 
 

Devices must be manufactured under a certified Quality Management System (QMS). They must also comply with the Essential Principles to ensure safety and performance. 
 

You must have in place effective supply and distribution processes. These keep devices safe and available to consumers. If you import or export implantable devices, you must comply with Australian regulations. 
 

Understanding these requirements helps you meet your legal obligations and manage risks throughout 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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