Regulations Medical Devices Australia

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

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 …

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 …

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. …

Therapeutic Goods (Medical Devices) Regulations 2002

https://www.legislation.gov.au/Details/F2022C00061

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 18 …

Medical devices | Therapeutic Goods Administration (TGA)

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

Medical devices reforms: An Action Plan for Medical Devices The Action Plan will further improve Australia’s medical device regulatory system and place patient safety first. 3 …

Therapeutic Goods (Medical Devices) Regulations 2002

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

12.2 Safety dependent on internal power supply. (1) This clause applies in relation to a medical device if the safety of a patient on whom the device is to be used will …

Advertising of medical devices - MTAA

https://www.mtaa.org.au/advertising-medical-devices

A company or a person may claim that they can arrange the supply of an unapproved medical device provided the unapproved device is supplied legally. Note that …

Medical devices - Australian Government Department of …

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

IVDs are regulated as medical devices. They include reagents, kits, calibrators, controls, laboratory analysers and software, as well as tests used at the point of care, or in the home, such as COVID-19 …