Australian Regulatory Medical Devices

Australian regulatory guidelines for medical devices …

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

Medical device (including IVD devices) inclusion process; On 23 July 2021 the Government repealed Regulation 4.1 and amended Regulation 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations). This means that from …

Medical devices regulation basics - Therapeutic Goods …

https://www.tga.gov.au/medical-devices-regulation-basics

Medical devices - Australian Government Department of …

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

Overview of medical devices and IVD regulation

https://www.tga.gov.au/overview-medical-devices-and-ivd-regulation

IVD medical devices are also regulated in Australia as a subset of medical devices. You may wish to check if your product is a medical device using the decision tool . What is …

Medical device reforms: Regulatory changes

https://www.tga.gov.au/medical-device-reforms-regulatory-changes

The Australian Government is undertaking a significant program of reforms to strengthen the regulation of medical devices in Australia (the Reforms). The Reforms aim to …

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 products, …

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 ...

Medical devices reforms | Therapeutic Goods …

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

The Medical Devices Reforms aim to enhance the safety, performance and quality of medical devices in Australia and focus on patient safety. About the Reforms The …

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 device registration & approval in Australia

https://www.emergobyul.com/services/medical-device-regulatory-overview-australia

Medical Device Regulatory Overview for Australia. Contact us. The Therapeutic Goods Administration (TGA), a unit of the Australian government’s Department of Health and Ageing, oversees medical …