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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 as therapeutic goods. We regulate medicines, medical devices and biologicals to help …

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    Medical device (including IVD devices) inclusion process; On 23 July 2021 the Government repealed Regulation 4.1 and amended Regulation 5.3 of the Therapeutic …

Medical devices regulation basics - Therapeutic Goods …

    https://www.tga.gov.au/medical-devices-regulation-basics

    Medical devices - Australian Government Department of …

      https://www.health.gov.au/topics/medical-devices

      Therapeutic Goods Administration (TGA) | Australian …

        https://www.health.gov.au/contacts/therapeutic-goods-administration-tga
        The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods such as medicines, medical devices, and diagnostic tests. Phone line …

      Regulation and compliance | Australian Government …

        https://www.health.gov.au/about-us/what-we-do/regulation-and-compliance
        our largest regulator the Therapeutic Goods Administration looks at prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood …

      Australia TGA Regulatory Approval Process for Medical Devices

        https://www.emergobyul.com/resources/australia-tga-regulatory-approval-process-medical-devices
        Step 1 Determine classification using Schedule 2 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002. If your device has European …

      Medical device registration & approval in …

        https://www.emergobyul.com/services/medical-device-regulatory-overview-australia
        Medical Device Regulatory Overview for Australia. Contact us. The Therapeutic Goods Administration (TGA), a unit of the Australian government’s Department of Health and …

      Clinical trials | Therapeutic Goods Administration (TGA)

        https://www.tga.gov.au/clinical-trials
        Clinical trial processes - Information relating to COVID-19 provides clarification about the clinical trial process as it relates to COVID-19. Clinical trials conducted in Australia are …



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