Regulation Medical Device Australia

Australian regulatory guidelines for medical devices …

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

On 23 July 2021 the Government repealed Regulation 4.1 and amended Regulation 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).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 28 July 2021, devices that were previously …

Medical devices regulation basics - Therapeutic Goods …

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

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 an …

Medical devices - Australian Government Department of …

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

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. Medical devices include a wide range of products, …

Therapeutic Goods (Medical Devices) Regulations 2002

https://www.legislation.gov.au/Details/F2017C00534

Part 1 — Preliminary. 1.1 Name of Regulations These Regulations are the Therapeutic Goods (Medical Devices) Regulations 2002.. 1.3 Definitions—the …

Therapeutic Goods (Medical Devices) Regulations 2002

https://www.legislation.gov.au/Details/F2020C00112

Part 1 — Preliminary. 1.1 Name of Regulations These Regulations are the Therapeutic Goods (Medical Devices) Regulations 2002.. 1.3 Definitions—the …

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 enhance …

Medical device registration & approval in …

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

The Therapeutic Goods Administration (TGA), a unit of the Australian government’s Department of Health and Ageing, oversees medical device regulation in Australia. …

Australia - Regulatory Market Profile Copy

https://www.rimsys.io/regulatory-market-profiles/australia

TGA Market Requirements. The Australian regulatory system has been based on recommendations of the former Global Harmonisation Task Force (GHTF), whose …