Chapter II Production License and Filing Management
Article 7 To engage in the production of medical devices, the following conditions shall be met:
(1) Having a production site, environmental conditions, production equipment and professional technicians suitable for the medical devices produced;
(2) Having a quality inspection institution for medical devices produced or full-time inspectors and inspection equipment;
(3) Having a management system to ensure the quality of medical devices;
(4) Having the ability of after-sales service suitable for the medical devices produced;
(five) meet the requirements of product development and production process documents.
Article 8 To set up Class II and Class III medical device manufacturing enterprises, they shall apply to the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government for production licenses, and submit the following materials:
(a) a copy of the business license and organization code certificate;
(2) A copy of the registration certificate and product technical requirements of the medical devices produced by the applicant enterprise; ?
(3) Copies of the identity certificates of the legal representative and the person in charge of the enterprise;
(four) the identity, education and title certificate of the person in charge of production, quality and technology;
(5) List of academic qualifications and titles of employees in production management and quality inspection positions;
(six) the production site certification documents, if there are special requirements for the production environment, it shall also submit a copy of the facilities and environmental certification documents;
(seven) the main production equipment and inspection equipment directory;
(eight) quality manuals and program documents;
(9) Process flow chart;
(10) authorization certificate of the agent;
(eleven) other supporting materials.
Article 11 To establish a Class I medical device manufacturing enterprise, it shall handle the production record of Class I medical devices with the municipal food and drug supervision and administration department located in the district, and submit a copy of the record certificate of medical devices produced by the filing enterprise and the materials specified in Article 8 of these Measures (except the second item).
The food and drug supervision and administration department shall inspect the integrity of the materials submitted by the enterprise on the spot, put them on record if they meet the prescribed conditions, and issue a record certificate for the production of Class I medical devices.
Extended data:
The distribution of names of medical devices after filing and the meanings represented by their numbers;
Seventy-first "medical device production license" and the format of the first class medical device production record certificate shall be uniformly formulated by China Food and Drug Administration.
The production license of medical devices shall be uniformly printed by the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government.
The serial number of the Medical Device Production License is XNo. XXXXXXXX from the Food and Drug Administration. These include:
The first X represents the abbreviation of the province, autonomous region or municipality directly under the Central Government where the licensing department is located; The second to fifth digits X represent the four-digit license year;
The sixth to ninth digits x represent the 4-digit license serial number.
The record number of the first class medical device production record certificate is arranged as: XX US Food and Drug Administration equipment XXXXXXXX. These include:
The first X represents the abbreviation of the province, autonomous region or municipality directly under the Central Government where the filing department is located;
The second X represents the abbreviation of the municipal administrative region where the filing department is located;
The third to sixth digits X represent the reporting year of the four digits;
The 7th to 10 x represents the 4-digit filing serial number.
State Food and Drug Administration of the United States-Measures for the Supervision and Administration of Medical Device Production (Order No.7 of China Food and Drug Administration)