Australian Regulatory Guidelines 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

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 …

Australian regulatory guidelines for medical devices …

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

Medical devices containing materials of animal, microbial or recombinant origin; Systems and ...

Medical device labelling obligations | Therapeutic Goods …

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

The person legally responsible for including a medical device on the Australian Register of Therapeutic Goods (ARTG), is referred to in the legislation as a 'Sponsor'. Regulation …

Therapeutic Goods (Medical Devices) Regulations 2002

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

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 1 …

IVD guidance documents | Therapeutic Goods …

https://www.tga.gov.au/ivd-guidance-documents

The GMDN is an international nomenclature system used by regional or national regulatory bodies to consistently describe medical devices U Updating an existing Class 1-3 in …

Australia TGA: Regulatory Guidelines for Medical Devices (ARGMD)

https://www.regulatoryaffairsnews.com/post/australia-tga-regulatory-guidelines-for-medical-devices-argmd

The Australian Regulatory Guidelines for Medical Devices (ARGMD) released updated guidance on 19-August-2022, which provides information on the import …

Medical devices reforms | Therapeutic Goods …

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

Strategy 1: Improve how new devices get on the market Implementation of a priority review pathway for medical devices Establishment of Australian Conformity Assessment …

(ARGMD) Part 3–Post-market - Therapeutic Goods …

https://www.tga.gov.au/sites/default/files/devices-argmd-p3.pdf

Australian Regulatory Guidelines for Medical Devices V1.1 May 2011 Page 294 of 337 Section 22. Post-market vigilance and monitoring requirements Overview Once a …