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On 23 July 2021 the Government repealed Regulation 4.1 and amended Regulation 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).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

The regulatory framework for medical devices spans the life of the device and includes: pre-market assessment: conformity assessment market authorisation: inclusion in the ARTG …

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. Listen. Medical devices include a wide range of products, …

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 …

IVD guidance documents | Therapeutic Goods …

https://www.tga.gov.au/ivd-guidance-documents

A manufacturer must be able to demonstrate that both the in vitro diagnostic medical device (IVD) and the manufacturing processes used to make the IVD conform to the …

Regulations For Medical Device Approval in Australia

https://credevo.com/articles/2020/07/25/australia-medical-device-approval-process/

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

Medical device registration & approval in Australia

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

Registering your device with the TGA entails risk-based classification; compliance with quality, safety and performance principles; compliance with regulatory controls for manufacturing processes; listing in the …