Article 76 The format of medical device registration certificate shall be uniformly formulated by the State Food and Drug Administration. The registration number is × 1 mechanical note× 2××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××× In which: × 1 is the abbreviation of the place where the registration examination and approval department is located: the word "country" is used for domestic Class III medical devices, imported Class II and Class III medical devices; The second category of medical devices in China refers to the provinces, autonomous regions and municipalities directly under the central government where the registration and approval departments are located; ×2 is the form of registration: the word "quasi" is applicable to domestic medical devices; The word "gold" is applicable to imported medical devices; The word "Xu" is applicable to medical devices in Hongkong, Macau and Taiwan Province. ××××× 3 is the year of first registration; ×4 is the product management category; ××5 is the product classification code; ××××× 6 is the first registered serial number. Continue to register, keep the number of ××××××× 3 and ×××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××× If the product management category is adjusted, it should be renumbered.
Article 77 The numbering method of the filing vouchers for Class I medical devices is × 1 equipment×××××××× 2×××××× 3. Where: × 1 is the abbreviation of the place where the filing department is located: the first category of imported medical devices is the word "country"; The first category of medical devices in China is the abbreviation of the province, autonomous region and municipality directly under the central government where the filing department is located plus the abbreviation of the municipal administrative region (there is no corresponding municipal administrative region with districts, but only the abbreviation of the province, autonomous region and municipality directly under the central government); ××××2 is the year of filing; ×××××× 3 is the serial number for filing.