Australian Medical Device Regulations 2002

Therapeutic Goods (Medical Devices) Regulations 2002

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

Therapeutic Goods (Medical Devices) Regulations 2002 (1) A quality management system that is to be assessed under clause 1.3 must meet the requirements of this clause. (2) The system must be of a kind such that its application will ensure that …

Therapeutic Goods (Medical Devices) Regulations 2002

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

Australian regulatory guidelines for medical devices …

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

Medical device (including IVD devices) inclusion process; On 23 July 2021 the Government repealed Regulation 4.1 and amended Regulation 5.3 of the …

Therapeutic Goods (Medical Devices) Regulations 2002

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

Therapeutic Goods (Medical Devices) Regulations 2002              (1)  The Secretary must, by written notice given to an Australian conformity assessment body, revoke the...

Therapeutic Goods (Medical Devices) Regulations 2002

https://www.legislation.gov.au/Details/F2020C00822

These Regulations are the Therapeutic Goods (Medical Devices) Regulations 2002. 1.3 Definitions—the dictionary etc (1) The dictionary at the end of …

Medical device labelling obligations | Therapeutic Goods …

https://www.tga.gov.au/resources/resource/guidance/medical-device-labelling-obligations

Essential Principle 13 of Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) outlines the requirements for information that must …

Medical devices regulation basics - Therapeutic Goods …

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

The Australian Register of Therapeutic Goods (ARTG) is the central database of therapeutic goods that can be legally supplied in or exported from Australia. Medical …

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

Australia Therapeutic Goods (Medical Devices) Regulations 2002 Brazil Brazilian Health Surveillance Agency Resolution RDC 16 2013 Resolution RDC 23 2012 Resolution RDC …

Essential principles checklist (medical devices)

https://www.tga.gov.au/resources/resource/forms/essential-principles-checklist-medical-devices

Essential principles checklist (medical devices) Last updated 15 September 2021 Listen Print Share It is the manufacturer's responsibility to demonstrate compliance with the essential …