Australian Medical Device Regulations 2022

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On 23 July 2021 the Government repealed Regulation 4.1 and amended Regulation 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).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

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 regulation basics - Therapeutic Goods …

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

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 enhance the …

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, …

Federal Register of Legislation - Australian Government

https://www.legislation.gov.au/Series/F2002B00237

Constitution Acts Legislative instruments Notifiable instruments Gazettes Bills Other Feedback Information Terms governing the use of this website. Home Legislative …

Therapeutic Goods (Medical Devices) Regulations 2002

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

1.7 Device nomenclature system codes (Act s 41BE(3)) Part 2—Essential principles 2.1 Essential principles (Act s 41CA) Part 3—Conformity assessment …

Therapeutic Goods Legislation Amendment (2022 …

https://www.legislation.gov.au/Details/F2022L00243

Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 I, General the Honourable David Hurley AC DSC (Retd), Governor‑General of the …

AUSTRALIA: Regulations of Software-Based Medical Devices – …

https://www.qualtechs.com/en-gb/australia-regulations-of-softwarebased-medical-devices-–-june-2022

AUSTRALIA: Regulations of Software-Based Medical Devices – June 2022 2022-06-29 Software, including mobile apps, is classified as a medical device under …

2022 medical device regulatory guidance …

https://www.emergobyul.com/news/us-fda-maps-out-medical-device-regulatory-guidance-planned-2022

The FDA CDRH lists provide a degree of transparency for US medical device market applicants and registrants in terms of where the regulator plans to commit …