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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- On 23 July 2021 the Government repealed Regulation 4.1 and amended Regulation 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).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 Administration (TGA) | Australian …
- https://www.tga.gov.au/
- We are Australia's government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods. We regulate …
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 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 …
Regulation and compliance | Australian Government …
- https://www.health.gov.au/about-us/what-we-do/regulation-and-compliance
- Regulation We set standards for the products and services you use and we then check regularly to make sure those standards are being met. For example: our largest regulator …
Therapeutic Goods (Medical Devices) Regulations 2002
- https://www.legislation.gov.au/Details/F2022C00061
- Therapeutic Goods (Medical Devices) Regulations 2002 Statutory Rules No. 236, 2002 made under the Therapeutic Goods Act 1989 Compilation No. 53 …
Medical devices reforms: Enhancements to post-market …
- https://www.tga.gov.au/medical-devices-reforms-enhancements-post-market-monitoring
- As a result of the responses to proposal 2 in the consultation, which sought feedback on strengthening reporting requirements for medical device adverse events, changes to the …
Therapeutic Goods (Medical Devices) Regulations 2002
- https://www.legislation.gov.au/Details/F2020C00112
- (1) A medical device, other than an IVD medical device, has the medical device classification applying under the classification rules set out in Schedule 2. …
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 procedure packs; Medical devices for export; Custom-made medical …
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 …
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