Australian Regulations For Medical Devices

Australian regulatory guidelines for medical devices …

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

Australian regulatory guidelines for medical devices (ARGMD) • For information on our regulation of medical devices go to Medical devices • For information on obtaining market authorisation go to Supply a medical device. • For information on …

Medical devices regulation basics - Therapeutic Goods …

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

Medical devices overview | Therapeutic Goods …

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

Medical devices include a wide range of products, such as medical gloves, bandages, syringes, blood pressure monitors, and x-ray equipment. They differ from medicines as …

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

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

Therapeutic Goods (Medical Devices) Regulations 2002

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

(1) A medical device, other than an IVD medical device, has the medical device classification applying under the classification rules set out in Schedule 2. …

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 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 …

Australian regulatory guidelines for medical devices …

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

The Australian Medical Device Requirements Under the Therapeutic Goods Act 1989 (version 4), or DR4, available on the TGA website, provides guidance for these products. …

Therapeutic Goods (Medical Devices) Regulations 2002

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

(1) A refurbishment of a medical device is taken to have occurred if the medical device, or a part of the device, is substantially rebuilt from one or more …