Certification of "medical device production license" guide
A, the name of the license
Medical device production license (second, third class) certification
Two, the statutory basis
1, "Chinese People's Republic of China **** and the State Administrative Licensing Act" (the Chinese People's Republic of China ****** and the President of the Decree) No. 7);
2, "supervision and management of medical devices regulations" (Chinese People's *** and State Council Decree No. 650, Article 22);
3, "supervision and management of the production of medical devices" (State Food and Drug Administration Decree No. 7, Article VIII;
4, the State Food and Drug Administration corresponding production implementation rules or production quality management standards. Norms and so on.
Three, reporting conditions
1. With "supervision and management of the production of medical devices," the provisions of Article VII;
2. Has obtained the second and third class of medical device product registration certificate;
3. In accordance with the relevant provisions of the industrial and commercial registration and obtain the organizational code certificate of the manufacturer;
4. Has the proposed production of products Production capacity; has been established in accordance with the "Medical Device Manufacturing Quality Management Standard" requirements for the production of medical devices quality management system;
5. Handle the production of medical devices license application personnel have the appropriate professional knowledge, familiar with the production of medical devices and quality management of the rules and regulations and technical requirements;
Division IV, the reporting information
Enterprises are required to submit the following application materials ( Paper in triplicate and electronic)
1, application for administrative license
2, "Medical Device Manufacturing License Application Form";
3, business license, organization code certificate copy;
4, the applicant holds the validity period of the production of medical devices and product registration certificate and a copy of the product technical requirements;
5, legal representative person, a copy of the identity of the person in charge of the enterprise, a copy of the person in charge of the enterprise's documents;
6, production, quality and technical personnel in charge of the identity of the person, a copy of the certificate of education, title;
7, production management, quality inspection positions of the practitioners of the academic qualifications, titles list;
8, the production site of the supporting documents (planning purposes or design uses should be appropriate), including proof of ownership of the house (or right of use). Including proof of property rights (or proof of right to use) or lease agreement and a copy of the tenant's proof of property rights (or proof of right to use); factory location road map, the factory's general layout (indicating the building number, floor and area), the main production workshop layout. Workshops with clean requirements, must indicate the cleanliness level of the functional rooms and the direction of the flow of people, logistics, and provide a copy of the clean room (including the inspection room) of the qualified test report (test report should be issued by the provincial food and drug supervision and management department recognized testing organizations within one year in line with the "production of aseptic medical devices management norms" (YY0033) of the qualified test report);
9, the main Production equipment and inspection equipment catalog;
10, quality manual and procedure documents catalog;
11, process flow diagram, (need to indicate the main production methods, outsourcing outsourcing parts, the main control items and control points, key and special processes, equipment, personnel and process parameters control of the description);
12, the application form for on-site inspection of the quality management standard for medical devices Self-inspection report (covering all products to apply for a production license) and on-site inspection of special instructions (such as applying for part of the product on-site assessment, written review or exemption from on-site assessment and other circumstances of the reasons and supporting information); on-site assessment after the submission of the on-site inspection report (including other explanations) and the results of unqualified items of the report on the rectification;
13, where the application for the enterprise declaration of materials, the processing staff is not the legal representative Person or person in charge of himself, the enterprise should submit the "power of attorney".
V. Format and Requirements
1, complete and clear declaration of information, three characters in imitation of the Song dynasty, using A4 paper printed or photocopied on one side, and in accordance with the requirements of the information in the order of preparation of directories and page numbers, bound in a book.
2, the declaration of information should be stamped; all copies should be indicated on the "this copy and the original in line with" or text description, and indicate the date and stamp; such as a single copy of more than 2 pages of information (including 2 pages) need to be stamped with a seam seal.
3, the documents submitted should be true and effective, and bear all legal responsibilities.
4, the operator's authorization certificate should specify the content of the commission, with a copy of the identity card of the trustee, the power of attorney should be signed by the legal representative and stamped with the official seal of the enterprise.