Medical Devices
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Resources

Guides from our team

Reference guides on how medical devices are regulated in Australia, for people new to the sector and for buyers.

Need product documentation?

We can provide ARTG details and supporting documentation for the products we supply, for your purchasing file or a contract submission.

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Regulation

Guide · Regulation

Medical device classifications explained: Class I to Class III

How the TGA's risk-based classes work, what they mean for ARTG inclusion, and why classification matters in procurement.

Read the guideGuide · Regulation

AS 5369 and the reprocessing changes: where single-use instruments fit

What AS 5369 changed for reprocessing, the dates that apply, and how sterile single-use instruments take items out of the reprocessing cycle.

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Thanks, your enquiry is on its way.A member of the team will be in touch within two business days. For anything urgent, call 1800 77 51 51.