Australian Medical Devices Guidelines

Australian regulatory guidelines for medical devices …

https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-medical-devices-argmd

The Australian Regulatory Guidelines for Medical Devices (ARGMD): provides information on the import into, export from and supply of medical devices within Australia. explains the legislative requirements that govern medical devices. …

Standards, guidelines & publications (medical devices

https://www.tga.gov.au/standards-guidelines-publications-medical-devices-ivds

All medical devices marketed in Australia must meet the requirements which are set out in Chapter 4 of the Therapeutic Goods Act 1989, and in the Therapeutic Goods (Medical …

Medical devices - Australian Government Department of …

https://www.health.gov.au/topics/medical-devices

Australian regulatory guidelines for medical devices …

https://www.tga.gov.au/resources/publication/publications/australian-regulatory-guidelines-medical-devices-argmd-v11-archived-version

medical devices in Australia. The ARGMD also describes post-market requirements for medical ...

Australian medical devices guidance document …

https://www.tga.gov.au/sites/default/files/devices-guidelines-35.pdf

The Medical Devices Information Unit of the Office of Devices, Blood and Tissues of the Therapeutic Goods Administration (TGA) can be contacted by: Telephone: Facsimile: …

Australia TGA: Regulatory Guidelines for Medical Devices (ARGMD)

https://www.regulatoryaffairsnews.com/post/australia-tga-regulatory-guidelines-for-medical-devices-argmd

The Australian Regulatory Guidelines for Medical Devices (ARGMD) released updated guidance on 19-August-2022, which provides information on the import …

Medical devices | Therapeutic Goods Administration (TGA)

https://www.tga.gov.au/products/medical-devices

Medical devices mainly work in a physical or mechanical way on the human body, or they’re used to measure or monitor it. Listen Medical devices include a wide range of …

Guidelines | NHMRC - National Health and Medical …

https://www.nhmrc.gov.au/guidelines

NHMRC guidelines are intended to promote health, prevent harm, encourage best practice and reduce waste. They are developed by multidisciplinary committees or panels that …

AUSTRALIAN MEDICAL DEVICES GUIDELINES

http://www.ahwp.info/sites/default/files/SG2__TGA_Guidlines___Post_Market_Activities%2C_Guidance_No._11.pdf

regulatory system for medical devices in Australia that commenced on 5 October 2002. The new system has been established by the Therapeutic Goods Ac, 1989 as amended …

Australian medical device guidelines - Therapeutic …

https://www.tga.gov.au/sites/default/files/devices-guidelines-14.pdf

Australian medical device guidelines – guidance document number 14, August 2003 Page 7 of 19 £ Category I (high infectivity), £ Category II (medium infectivity), or £ Category …