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The ARGMD is a consolidated reference document detailing the regulatory requirements for medical devices in Australia.
The ARGMD describes the information to be supplied with applications to:
medical devices in Australia. The ARGMD also describes post-market requirements for medical devices.
Regulatory guidance on other therapeutic devices that are listed or registered is not included. The Australian Medical Device Requirements Under the Therapeutic Goods Act 1989 (version 4), or DR4, available on the TGA website, provides guidance for these products. Therapeutic devices include:
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The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.