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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

  • Supply a medical device

    Page
    Guidance on how to supply medical devices in Australia, including requirements for ARTG inclusion, application processes, sponsor responsibilities, and ongoing compliance and post-market obligations.

Steps to supply (manufacturer) 

Medical device reforms

  • 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.

Guidance documents

Labelling and instructions for use

Clinical evidence guidelines

Patient implant cards and information leaflets

Sponsors and manufacturers

Related links

Australian Regulatory Guidelines for Medical Devices (ARGMD)
Manufacturing medical devices and where to start
Manufacturing medical devices and IVDs
Essential Principles checklist
Supply a medical device
Medical device inclusion process
Guidelines for sterility testing of therapeutic goods
Export of medical devices
Application for medical device priority applicant determination
Product types
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