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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. Medical devices include a wide range of products, such as medical gloves, bandages, syringes, blood pressure monitors, and X-ray …

Medical devices & IVDs | Therapeutic Goods …

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

Australian regulatory guidelines for medical devices …

    https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-medical-devices-argmd
    The Australian Regulatory Guidelines for Medical Devices (ARGMD): provides information on the import into, export from and supply of medical devices within …

Therapeutic Goods Administration (TGA) | Australian …

    https://www.tga.gov.au/
    Therapeutic Goods Administration (TGA) We are Australia's government authority responsible for evaluating, assessing and monitoring products that are defined …

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 …

Medical devices notices & standards orders

    https://www.tga.gov.au/medical-devices-notices-standards-orders
    Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Determination 2018- external siteDetermines the kind and form of information …

Class 1 medical devices - Therapeutic Goods …

    https://www.tga.gov.au/medical-devices-reforms-low-risk-products-class-1-medical-devices
    Project overview. Appropriate regulation of low risk devices improves their availability. The regulation of low risk Class I medical devices is still under review, to remove …

Database of Adverse Event Notifications (DAEN)

    https://www.tga.gov.au/database-adverse-event-notifications-daen-medical-devices
    The Database of Adverse Event Notifications - medical devices contains information from reports of adverse events that the TGA has received in relation to medical devices used …

Australian TGA knocks back Hydrix’ (ASX:HYD) Guardian device

    https://themarketherald.com.au/australian-tga-knocks-back-hydrix-asxhyd-guardian-device-2023-02-15/
    The Australian Therapeutic Goods Administration (TGA) has rejected Hydrix’ (HYD) application for its implanted heart monitoring system to be distributed in …



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