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China institutes new medical device label requirements

  • 1.  China institutes new medical device label requirements

    Posted 15-Feb-2019 14:08

    Starting January 1, China began requiring detailed labeling and descriptions in Chinese on most medical device products sold in the country.

    The new regulations from China's National Medical Products Administration, the administrative body responsible for the regulation of medical devices and pharmaceuticals on the Chinese mainland, apply to all Class I, Class II, and Class III device manufactured after January 1.

    The regulations mandate using simplified Chinese characters for the device name and descriptions and ensuring that label descriptions correspond precisely to the description <g class="gr_ gr_25 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar multiReplace" id="25" data-gr-id="25">on</g> the product registration.


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