: with the scope of business and the scale of operation of the quality management institutions or quality management personnel, quality management personnel should have a nationally recognized relevant professional qualifications or titles. Required materials: a copy of the business license; legal representative, the person in charge of the enterprise, the quality of the person in charge of the identity card, a copy of the certificate of academic qualifications or titles, etc..
Conditions:
Engaged in the medical device business, should have the following conditions:
(a) with the scope of business and the scale of operation of the quality management organization or quality management personnel, quality management personnel should have a nationally recognized professional qualifications or titles;
(b) with the scope of business and the scale of operation of the business, storage premises;
(c) with the scope of business and the scale of business, storage premises;
(d) with the scope of business, storage premises;
(e) with the scope of business, storage premises. Business, storage space;
(C) with the scope of business and business scale appropriate storage conditions, all entrusted to other medical device business enterprises can not set up storage;
(D) with the operation of the medical device quality management system;
(E) with the operation of the medical device appropriate professional guidance, technical training and After-sales service capacity, or agreed to provide technical support by the relevant organizations.
Enterprises engaged in the operation of Class III medical devices should also have a computerized information management system that meets the requirements of quality management of medical device business, to ensure that the operation of the product can be traced. Encouraged to engage in the first class, the second class of medical devices business enterprises to establish a quality management of medical equipment business in line with the requirements of the computer information management system.
Legal basis
"Supervision and Administration of Medical Devices"
Article X. Engaged in the operation of Class III medical devices, the business enterprise shall apply to the municipal level responsible for the supervision and administration of drugs at the location of the municipal level, and submit the following information:
(a) legal representative (the enterprise), responsible for quality, the person in charge of identity certification, the person in charge of quality. (person in charge), the quality of the person in charge of identification, education or title copies of relevant materials;
(b) enterprise organization and departmental settings;
(c) medical equipment business scope, business mode;
(d) business premises and warehouse location map, floor plan, house ownership documents or copies of lease agreements;
(e) The main operating facilities, equipment directory;
(F) business quality management system, work procedures and other documents directory;
(G) the basic information management system;
(H) the authorization of the operator documents.
The applicant for a medical device license shall ensure that the information submitted is legal, true, accurate, complete and traceable.