Australia Medical Device Regulations

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On 23 July 2021 the Government repealed Regulation 4.1 and amended Regulation 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).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 described …

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

Medical devices including IVD medical devices are assessed against the Essential Principles and in line with their intended purpose and risk-based classification. The …

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

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, such as …

Therapeutic Goods (Medical Devices) Regulations 2002

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

This is a compilation of the Therapeutic Goods (Medical Devices) Regulations 2002 that shows the text of the law as amended and in force on 1 July 2017 …

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 dictionary …

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 MRA - Australian Medical Devices Regulations

https://www.sgs.com/en-ca/services/australia-mra-australian-medical-devices-regulations

Only a few Notified Bodies such as SGS have been approved by the Therapeutic Goods Administration (TGA) under this MRA for the Australian medical devices regulations. …