The following are the requirements for manufacturing enterprises
Application conditions
The following conditions must be met in order to start a Class II and Class III medical device manufacturing enterprise:
(a) There are production sites, environmental conditions, production equipment and professional and technical personnel that are appropriate for the production of medical devices;
(b) There is a quality inspection organization or full-time staff that conducts quality inspections of the medical devices produced. (B) the production of medical devices for quality inspection organizations or full-time inspectors and inspection equipment;
(C) have to ensure that the quality of medical devices management system;
(D) with the production of medical devices compatible with after-sales service capabilities;
(E) in line with the requirements of product development, production process documentation.
(F) has obtained the second and third medical device product registration certificate, has been in accordance with the relevant provisions of the business registration;
(VII) has been in accordance with the "Good Manufacturing Practice for Medical Devices" requirements for the establishment of quality management system for the production of medical devices;
(VIII) to handle the application for a license for the production of medical devices have the appropriate professional knowledge and familiarity with the medical device Production quality management rules, regulations and technical requirements.
Three, reporting information and requirements
Open
Open
Organization of the second class, the third class of medical device manufacturers should be located in the provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration to apply for production licenses, the first through the State Food and Drug Administration website home page, "online business "column in the" medical device production and operation license filing information system "click to enter and follow the prompts in the online submission of the following information and then print the written information (in duplicate) to the provincial government government service center Food and Drug Administration window on-site application:
(a) The Medical Device Manufacturing License Application Form" (see Annex 1);
(ii) a copy of the business license, organization code certificate;
(iii) a copy of the registration certificate of the medical device and product technical requirements of the medical device produced held by the applicant enterprise;
(iv) a copy of the identity of the legal representative and the person in charge of the enterprise, including proof of identity, proof of academic qualifications, proof of professional title , a copy of the appointment documents and work resume;
(e) production, quality and technical personnel in charge of the identity, education, title certificates copies;
(f) production management, quality inspection positions practitioners list of academic qualifications, titles;
(g) the production site of the supporting documents, including proof of the real estate or lease agreement and the leased party's real estate certificate copies Workshops with clean requirements, shall be marked with functional rooms and people (material) flow towards; special production environment requirements should also be submitted to the facilities, environment, a copy of the supporting documents (clean room inspection report should be recognized by the provincial food and drug supervision and management department of the testing agency within one year in line with the "production of aseptic medical devices management norms" (YY0033) of the qualified test reports);
< p>(viii) Catalog of main production equipment and inspection equipment;(ix) Quality manual and procedure documents, the contents of which should be in line with the provisions of the Code of Practice for the Manufacture and Administration of Medical Devices;
(x) Process flow diagrams with the main control items and control points, including the key and special processes, equipment, personnel, and process parameters to control the description;
(xi) Declaration of the authenticity of the material self-assurance statement, including the enterprise to the material to make a commitment to bear legal responsibility if false;
(xii) Where the application for the enterprise declaration materials, the person handling the material is not the legal representative or the person in charge himself, the enterprise should submit the "power of attorney";
(xiii) declaration of the filing of information in the directory (see Annex 2). Enterprise filing information should be arranged in directory order bound, directory (serial number) the first page for the label or separated by tabbed divider paper; in accordance with the principle of separate coding of sub-directory (serial number), the starting page for the first page ("1-x") marked page number; information page numbers are marked with Arabic numerals in the lower right corner / lower left corner (with black) Carbon pen handwritten / printed).