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Singapore Drafts New Guidelines On Lab-Developed Tests (LDTs)

  • 1.  Singapore Drafts New Guidelines On Lab-Developed Tests (LDTs)

    Posted 21-Sep-2022 16:30
    Last month, Singapore's HSA provided a draft guideline on LDTs. This guideline stated that LDTs used as IVDs or for RUO are not classified as LDTs. LDTs are tests that are only developed and used by labs at their own sites. Labs that develop LDTs are licensed under the Singapore HSA. LDTs must meet relevant quality management systems as well as post-market requirements.

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    Ames Gross
    President
    Pacific Bridge Medical
    Bethesda, MD
    www.pacificbridgemedical.com
    contact@pacificbridgemedical.com
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