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Therapeutic Goods (Medical Devices) Regulations 2002
- https://www.legislation.gov.au/Details/F2017C00534
- Part 1 — Preliminary. 1.1 Name of Regulations These Regulations are the Therapeutic Goods (Medical Devices) Regulations 2002.. 1.3 Definitions—the dictionary etc (1) The dictionary at the end of these Regulations defines certain words and …
Therapeutic Goods (Medical Devices) Regulations 2002
- https://www.legislation.gov.au/Details/F2022C00061
- This compilation. 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 …
Therapeutic Goods (Medical Devices) Regulations 2002
- https://www.legislation.gov.au/Details/F2012C00424
- These Regulations are the Therapeutic Goods (Medical Devices) Regulations 2002. 1.2 Commencement [see Note 1] These ... For these Regulations, a …
TGA REGULATORY UPDATE December 2020
- https://www.fda.gov/media/146225/download
- amendment-2019-measures-no1-regulations-2019. 11. Unique Device Identification (UDI) • Second consultation period closed 2 Dec 2020 ... introduced into the Therapeutic Goods …
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
- Therapeutic Goods (Medical Devices) Regulations 2002; Brazil. ... Resolution RDC 16 2013; Resolution RDC 23 2012; Resolution RDC 67 2009; Canada. Medical Devices …
Therapeutic Goods Administration (TGA) …
- https://www.mastercontrol.com/gxp-lifeline/transition-plan-from-custom-device-to-patient-matched/
- As of the February 25, 2021, the December 2019 amendment of the Therapeutic Goods (Medical Devices) Regulations 2002 relating to the regulation of personalized medical …
Medical devices regulation basics - Therapeutic Goods …
- https://www.tga.gov.au/medical-devices-regulation-basics
- Overview: Regulation of medical devices and in vitro diagnostic (IVD) devices; Other therapeutic goods that are not medical devices, medicines or biologicals (such as …
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- Medical device (including IVD devices) inclusion process; On 23 July 2021 the Government repealed Regulation 4.1 and amended Regulation 5.3 of the …
Medical device labelling obligations | Therapeutic Goods …
- https://www.tga.gov.au/resources/resource/guidance/medical-device-labelling-obligations
- All medical devices supplied in Australia must meet the relevant Essential Principles for safety and performance to ensure the device is safe and performs as intended. Essential …
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