Article 76 The format of the medical device registration certificate is uniformly formulated by the State Food and Drug Administration. The registration certificate number is arranged as follows: × 1 mechanical note × 2 ××××3 × 4 × × 5 ××××6. Where: × 1 for the registration and approval department of the location of the abbreviation: domestic Class III medical devices, imported Class II, Class III medical devices for the "country"; domestic Class II medical devices for the registration and approval of the department of the location of the province, autonomous region, municipality directly under the Central Government abbreviation; × 2 for the registration and approval department of the location of the province, autonomous region, municipality directly under the Central Government abbreviation The abbreviation of province, autonomous region, municipality directly under the central government; ×2 for the registration form: "quasi" applies to the domestic medical devices; "into" applies to imported medical devices; "permit" applies to Hong Kong, Macao, Taiwan's medical devices; 3.com, Medical devices in Hong Kong, Macao, Taiwan; ××××3 for the first registration year; × 4 for the product management category; × × 5 for the product classification code; ××××6 for the first registration number. Renewal of registration, ××××3 and ××××6 figures remain unchanged. Product management category adjustment, should be renumbered.
Article 77 of the first class of medical devices for the record voucher number is organized as follows: × 1 mechanical preparation ××××2 ××××3 number. Among them: × 1 for the record of the location of the department of the abbreviation: imported Class I medical devices for the "country"; domestic Class I medical devices for the record of the department's location in the province, autonomous region, municipality directly under the Central Government for the abbreviation of the location of the municipal administrative region (without the corresponding district of the municipal administrative region, only for the province, autonomous region, municipality directly under the Central Government for the abbreviation of the province, autonomous region, municipality directly under the Central Government for the abbreviation of the province, autonomous region, municipality directly under the Central Government for the abbreviation) ××××2 for the record year; ××××3 for the record running number.