Basic information editing

Medical device registration is a process in which the Food and Drug Administration, according to the application of the medical device registration applicant and in accordance with legal procedures, conducts a systematic evaluation of the safety, efficacy research and results of the medical device to be marketed, and decides whether to approve the application. .

  Regulatory RegulationsEdit

  1. "Regulations on the Supervision and Administration of Medical Devices" (Order No. 650 of the State Council) issued on March 7, 2014

  2. "Measures for the Administration of Medical Device Registration" (Order No. 4 of the State Food and Drug Administration) released on July 30, 2014

  3. "Administrative Measures for the Registration of In Vitro Diagnostic Reagents" (Order No. 5 of the State Food and Drug Administration) released on July 30, 2014

  Certificate Number Code

   Medical device registration number consists of six parts, the basic arrangement is: X(X)1 Food and Drug Administration (X2) word XXXX3 No. X4XX5XXXX6.

   Among them, X1 is the abbreviation of the location of the registration approval department. Domestic Class III medical devices, overseas medical devices, and medical devices in Taiwan, Hong Kong, and Macau are the word "country". The domestic second-class medical device is the abbreviation of the province, autonomous region or municipality directly under the Central Government where the registration approval department is located. The domestic first-class medical device is the abbreviation of the province, autonomous region, and municipality directly under the Central Government where the registration approval department is located plus the abbreviation of the municipal administrative region divided into districts. When it is a municipal-level administrative region without corresponding districts in XX1, it is only the abbreviation of province, autonomous region, and municipality directly under the Central Government. X2 is the registration form (quasi, advanced, permitted). The word "Zhun" applies to domestic medical devices, the word "Jin" applies to overseas medical devices, and the word "Xu" applies to medical devices in Taiwan, Hong Kong, and Macau. XXXX3 is the year of approval for registration, X4 is the product management category, and XX5 is the product variety code. XXXX6 is the registration serial number.

   On October 1, 2014, the new version of the "Administrative Measures for Medical Device Registration" came into effect, and the "Administrative Measures for Medical Device Registration" (former State Food and Drug Administration Order No. 16) promulgated on August 9, 2004 was repealed at the same time. The new version of the "Administrative Measures for Medical Device Registration" has re-formulated the way of compiling the certificate number:

  The arrangement of the registration certificate number is as follows:

  ×1 Mechanical Note×2××××3×4××5××××6. in:

  ×1 is the abbreviation of the location of the registration approval department:

   The domestic third-class medical device, imported second-class and third-class medical devices are the word "country";

   Domestic Class II medical devices are the abbreviations of the provinces, autonomous regions, and municipalities directly under the Central Government where the registration approval authority is located;

  ×2 is the registration form:

   The word "quasi" applies to domestic medical devices;

   The word "jin" applies to imported medical devices;

   "Xu" is applicable to medical devices in Hong Kong, Macau and Taiwan;

  ××××3 is the year of first registration;

  ×4 is the product management category;

  ××5 is the product classification code;

  ××××6 is the serial number for the first registration.

   For continuation of registration, the numbers of ××××3 and ××××6 remain unchanged. If the product management category is adjusted, it shall be renumbered.

  The arrangement of the registration certificate number for the first class medical device is as follows:

  ×1 Mechanical Equipment××××2××××3.

  in:

  ×1 is the abbreviation of the location of the filing department:

   Imported first-class medical equipment is the word "country";

  The domestic first-class medical device 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 city-level administrative region divided into districts (if there is no corresponding city-level administrative region divided into districts, it is only the abbreviation of the province, autonomous region, and municipality directly under the Central Government);

  ××××2 is the filing year;

  ××××3 is the serial number for the record.