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Malaysia releases new draft IVD and medical device regulations

  • 1.  Malaysia releases new draft IVD and medical device regulations

    Posted 13-Apr-2020 16:33
    Under draft classification guidance released by Malaysian health regulators, in vitro diagnostics tests on blood, tissue and other samples in Malaysia would be separated into four categories based on the risk they pose to consumers. The new draft regulations were released in March by Malaysia’s Medical Device Authority (MDA). The MDA is also drafting guidance to classify medical devices into five categories, depending on how they are packaged and sold.

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