Medical Devices Regulations 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

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. …

Medical devices - Australian Government Department of …

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

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/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 …

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 …

Medical devices | Therapeutic Goods Administration (TGA)

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

Medical devices include a wide range of products, such as medical gloves, bandages, syringes, blood pressure monitors, and X-ray equipment. While the objective of these …

MDSAP International Regulations [English] (Australia, …

https://www.fda.gov/medical-devices/medical-device-single-audit-program-mdsap/mdsap-international-regulations-english-australia-brazil-canada-japan-and-usa

21CFR806--Subchapter H--Medical Devices--Part 806 Medical Devices; Reports of Corrections and Removals 21 CFR 807 - ESTABLISHMENT REGISTRATION AND …

Therapeutic Goods (Medical Devices) Regulations 2002

https://www.legislation.gov.au/Details/F2012C00424

(1) For paragraph 41EA (a) of the Act and subject to subregulation (3), the kind of manufacturer in respect of whom a conformity assessment certificate must be issued …