Legal analysis: should be to the location of the provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration to apply for production permits, with business license, organization code certificate copy, the applicant enterprise held by the production of medical devices registration certificate and product technical requirements copy, legal representative, the person in charge of the enterprise copy of the identity card, production, quality and technology responsible person's identity, education, title A copy of the certificate, production management, quality inspection positions practitioners list of academic qualifications, titles, production site documents, there are special production environment requirements should also be submitted to the facilities, the environment of the copy of the documents, the main production equipment and inspection equipment catalog, quality manuals and procedural documents, etc..
Legal basis: "Supervision and Administration of Medical Devices Regulations"
Article VII engaged in the production of medical devices, shall have the following conditions:(a) with the production of medical devices and production sites, environmental conditions, production equipment, and professional and technical personnel;
(b) the production of medical devices to carry out quality testing of the organization or full-time inspection (B) the production of medical devices for quality inspection of institutions or full-time inspection equipment;
(C) to ensure the quality of medical devices management system;
(D) with the production of medical devices compatible with the after-sales service capabilities;
(E) in line with the product development, production process documentation requirements. Article VIII to open the second class, the third class of medical device manufacturers, shall apply to the local provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration for production permits, and submit the following information: (a) a copy of business license, organization code certificate; (b) the applicant company holds a copy of the registration certificate of the production of medical devices and product technical requirements; (c) the legal representative, the person in charge of the enterprise Copy of identification; (d) production, quality and technical personnel in charge of the identity, education, title certificate copies; (e) production management, quality inspection positions practitioners education, title list; (f) production site documents, there are special production environmental requirements should also be submitted to the facilities, environment, copies of documents; (g) the main production equipment and inspection equipment catalog; (h) quality manuals and procedural documents; (ix) process flow diagrams; (x) proof of authorization by the operator; (xi) other supporting information.