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Australian regulatory guidelines for medical devices (ARGMD), V1.1

V1.1, May 2011

23 October 2018

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:

  • import
  • export
  • manufacture
  • supply

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:

  • tampons
  • surface disinfectants
  • devices incorporating human materials

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Complete ARGMD document

Individual parts of ARGMD
Part Contents
  1. Introduction to the regulatory guidelines
  2. Fees and charges for medical devices
  3. The essential principles
  4. Classification of medical devices
  5. Conformity assessment overview
  6. What a manufacturer needs to know about conformity assessment
  7. What a sponsor needs to know about conformity assessment
  8. Differences between the Australian and European Union medical device regulatory requirements
  9. International agreements
  1. Including medical devices in the ARTG
  2. Application audits of medical device applications
  3. Information about a medical device
  4. Active medical devices
  5. Medical devices incorporating a medicine
  6. Medical devices containing materials of animal, microbial or recombinant origin
  7. Systems and procedure packs
  8. Medical devices for export
  9. Custom-made medical devices
  10. Single-use devices (SUDs) and the reuse of SUDs
  11. Access to unapproved medical devices in Australia
  1. Changes to ARTG Inclusions
  2. Post-market vigilance and monitoring requirements
  3. Recalls, suspensions, cancellations and tampering of medical devices
  1. Bibliography
  2. Contact Details
  3. Glossary
  • Index