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Medical devices regulation basics - Therapeutic Goods …
- https://www.tga.gov.au/medical-devices-regulation-basics
- There are several ways to get information about changes to Australia's medical device regulations: Subscribe to the fortnightly TGA UPDATE email; Regularly check the Latest news and updates page; Keep up with Consultations and reviews page; Follow the progress of the Medical Devices … See more
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- Medical device (including IVD devices) inclusion process; On 23 July 2021 the Government repealed Regulation 4.1 and amended Regulation 5.3 of the …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 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, …
Overview of medical devices and IVD regulation
- https://www.tga.gov.au/overview-medical-devices-and-ivd-regulation
- IVD medical devices are also regulated in Australia as a subset of medical devices. You may wish to check if your product is a medical device using the decision tool. What is an IVD …
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 …
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 overview | Therapeutic Goods …
- https://www.tga.gov.au/products/medical-devices/medical-devices-overview
- How the TGA regulates medical devices in Australia Overview of medical devices and IVD regulation Transvaginal mesh hub Information on breast implant associated cancer …
TGA REGULATORY UPDATE December 2020
- https://www.fda.gov/media/146225/download
- • TGA is the first regulator to introduce the concept • A validated, multi- component design and production system that a manufacturer can supply to health professionals and …
Legislation and legislative instruments | Therapeutic …
- https://www.tga.gov.au/about-tga/legislation/legislation-and-legislative-instruments
- Legislation and legislative instruments The Therapeutic Goods Act, Regulations and Orders set out the requirements for inclusion of therapeutic goods in the Australian Register of …
Therapeutic Goods Administration (TGA) …
- https://www.mastercontrol.com/gxp-lifeline/transition-plan-from-custom-device-to-patient-matched/
- Changes to exemption conditions and arrangements for custom devices, introducing requirements such as annual reporting (of distributed units and adverse events), authorizations for the …
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