In Vitro Diagnostic medical devices (IVDs)
Information on In Vitro Diagnostic medical devices (IVDs).
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Our response to questions asked about the Essential Principles consultation
Following our Essential Principles presentations on 11-12 September 2024, we have collated questions asked into themes to simplify finding information of relevance to you. -
Enforceable undertaking: 2San Pty Ltd
We have accepted an enforceable undertaking from 2San Pty Ltd in relation to breaches of the Therapeutic Goods Act 1989. This relates to the company's unlawful import and supply of medical devices. -
2San Pty Ltd enters into enforceable undertaking after unlawful import and supply of medical devices
The company imported medical devices not included in the Australian Register of Therapeutic Goods. They supplied these devices to a national retailer, who then sold them to the public.
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Read the meeting statement from 8 February 2024 meeting of the Advisory Committee on Medical Devices (ACMD).
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Read the meeting statement from 7 December 2023 meeting of the Advisory Committee on Medical Devices (ACMD).
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Read the meeting statement from 12 October 2023 meeting of the Advisory Committee on Medical Devices (ACMD).
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Consultation: Proposed changes to the IVD medical device classifications and definitions
We are seeking stakeholders’ feedback on proposed changes to the IVD medical device classifications and definitions.