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    Announcement of the State Food and Drug Administration on th

    State Food and Drug Administration
    Notice
    2014 twenty-third
    Announcement on the implementation of the regulations on supervision and administration of medical devices (No. twenty-third)
    "Medical equipment supervision and management regulations" has been revised in February 12, 2014 by the thirty-ninth executive meeting of the State Council, the implementation of the regulations since June 1, 2014. State Food and drug administration is paying close attention to the revision of the "medical equipment supervision and management regulations," supporting regulations and regulatory documents will be released. The relevant matters concerning the implementation of the regulation on supervision and administration of medical devices are hereby promulgated as follows:
    First, the product registration management
    In the State Food and Drug Administration of the relevant new regulations and normative documents before the introduction of product registration management in accordance with the existing provisions of the implementation.
    After June 1, 2014 to make a decision to be registered, the product registration certificate is valid for 5 years.
    Two, on the production and operation management
    In the State Food and drug administration new regulations and normative documents issued before the medical equipment manufacturing enterprises and engaged in second types, third types of medical equipment business, the management in accordance with the existing regulations and normative documents execution.
    Three, investigate and deal with violations
    Medical violations occur before June 1, 2014, apply before the revision of the "medical equipment supervision and management regulations", but the new revised "the supervision and administration of medical devices regulations" that is illegal or lighter punishment, supervision and administration of medical devices regulations for the newly revised "". Illegal acts occurred in June 1, 2014 after the application of the newly revised "medical equipment supervision and management regulations".
    Hereby announcement.
    State Food and Drug Administration
    May 23, 2014