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Manufacture a medical device

Regulatory responsibilities and expectations for manufacturers of medical devices, including in vitro diagnostics (IVDs).

Last updated

Medical devices imported into, supplied in, or exported from Australia must be included in the Australian Register of Therapeutic Goods (ARTG). This needs to be done by the device's Australian sponsor.

Medical devices must comply with the Essential Principles, which set out fundamental safety and performance requirements.

Content from the Australian Regulatory Guidelines for Medical Devices (ARGMD) has been broken up and included as individual pages and documents on our new website.

Key information 

To help confirm you have a medical device use our online tool: Is my product a medical device? 

For information on market authorisation and the ARTG inclusion process for medical devices, including IVDs go to Supply a medical device.

Sponsors of medical devices with medicinal substances can find more information on the Medicinal substances in medical devices webpage.

Steps to supply (manufacturer) 

Medical device reforms

Follow the link below for information about recent and upcoming regulatory changes..

  • Medical devices reforms

    Page
    The Medical Devices Reforms aim to enhance the safety, performance, and quality of medical devices in Australia and focus on patient safety.

More information

Labelling and instructions for use

Clinical evidence guidelines

Patient implant cards and information leaflets

Consumers, patients and health professionals

Sponsors and manufacturers

Priority review pathway

COVID-19

Action Plan for Medical Devices

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