every province Autonomous Region Municipal Drug Administration,Drug administration of Xinjiang production and Construction Corps

For implementation Regulations on the supervision and administration of medical devices Order of the State Council No739number requirement,according to Administrative measures for registration and filing of medical devices Order of the State Administration of market supervision No47number and Administrative measures for registration and filing of in vitro diagnostic reagents Order of the State Administration of market supervision No48number ,The National Bureau organized the revision Code of practice for registration and approval of domestic class II medical devices ,It is hereby printed and distributed,Effective as of the date of promulgation. Notice of the State Food and Drug Administration on printing and distributing the operation specifications for the registration and approval of domestic class II medical devices Food and Drug Administration 2014 209number Repeal at the same time.

enclosure Code of practice for registration and approval of domestic class II medical devices

      Details can be obtained through the following QR code.

State Food and Drug Administration

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