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Australian regulatory guidelines for medical devices (ARGMD), V1.1
V1.1, May 2011
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:
- surface disinfectants
- devices incorporating human materials
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Complete ARGMD document
- Australian Regulatory Guidelines for Medical Devices (ARGMD) (pdf,2.51Mb)
- Australian Regulatory Guidelines for Medical Devices (ARGMD) (docx,2.32Mb)