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11 result(s) found, displaying 1 to 11
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NewsFollowing our Essential Principles presentations on 11-12 September 2024, we have collated questions asked into themes to simplify finding information of relevance to you.
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Compliance undertakingsWe 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.
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2San Pty Ltd enters into enforceable undertaking after unlawful import and supply of medical devices
Media releasesThe 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. -
NewsTo help sponsors and manufacturers transition to new manufacturer evidence.
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NewsTransition period for accepting ISO 13485 ends 26 May 2023.
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NewsThe TGA will recognise the extended transition for the European Union Medical Device Regulation (EU MDR).
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Media releasesThe TGA has approved the first two nasal combination self-tests (for use at home) that detect both COVID-19 and influenza viral infections in humans.
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NoticesNew legislative instrument
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NewsInvitation to the National Measurement Institute's mask/respirator testing forum.
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NewsChanges will be made to the regulation of nappy rash products on 1 January 2020
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NoticesTherapeutic Goods Order No. 1 of 2010.