Medical device registrants, filers can sell their own, but also can be entrusted to the medical device business enterprises to sell their registered, filed medical devices. Article IV in accordance with the degree of risk of medical devices, medical devices business implementation of classification management.
The operation of Class III medical devices license management, the operation of Class II medical devices for the record management, the operation of Class I medical devices do not require licensing and filing. Article V of the State Drug Administration in charge of the national supervision and management of medical devices.
Provinces, autonomous regions, municipalities directly under the Central Drug Administration is responsible for the administrative region of the supervision and management of medical devices.
Settlement of municipalities, county-level drug supervision and management departments responsible for the administrative region of the supervision and management of medical devices. Article drug supervision and management departments set up or designated by law, medical device inspection, testing, monitoring and evaluation of professional and technical institutions, in accordance with the division of responsibilities to undertake the relevant technical work and issue technical advice for the supervision and management of medical devices to provide technical support. Article 7 The State Drug Administration to strengthen the supervision and management of medical devices information construction, improve the level of online government services.
Provinces, autonomous regions, municipalities directly under the Central Drug Administration is responsible for the administrative region of medical device management supervision and management of information construction and management, in accordance with the State Drug Administration requirements to promote the supervision and management of medical devices information **** enjoy. Article 8 The drug supervision and management department in accordance with the law timely disclosure of medical device business license, filing and other information, as well as supervision and inspection, the results of administrative penalties, to facilitate public inquiries, accept social supervision. Chapter II business license and record management Article IX engaged in the operation of medical devices, shall 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 the relevant professional qualifications or titles;
(b) with the scope of business and the scale of operation of the appropriate business premises;
(c) with the scope of business and business scale appropriate storage conditions;
(d) with the operation of medical devices appropriate quality management system;
(e) with the operation of medical devices appropriate professional guidance, technical training and after-sales service quality management organization or personnel.
Enterprises engaged in the operation of Class III medical devices should also have a computerized information management system that meets the requirements of the quality management system for the operation of medical devices, 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 system in line with the requirements of medical equipment business computer information management system. Article X engaged in the operation of Class III medical devices, the business enterprise shall be located in the municipal level responsible for drug supervision and management of the application, and submit the following information:
(a) legal representative (person in charge of the enterprise), the quality of the person in charge of the identity card, education or title copies of relevant materials;
(b) the enterprise's organizational structure and departmental setup;
(c) the scope of medical device business, business mode;
(d) business premises and warehouses of the geographic location of the map, floor plan, building ownership documents or copies of lease agreements;
(e) the main operating facilities, equipment catalog;
(f) business quality management system, work procedures and other documents catalog;
(g) information management system Basic information;
(viii) the operator's authorization documents.
Applicants for medical device license shall ensure that the information submitted is legal, true, accurate, complete and traceable. Article XI of the municipal level responsible for drug supervision and management of the application received by the department shall be processed in accordance with the following circumstances:
(a) the application belongs to the terms of reference of the administrative organ, the application information is complete, in accordance with the statutory form, the application shall be accepted.
(2) application information there can be corrected on the spot error, the applicant shall be allowed to correct on the spot.
(C) the application information is incomplete or does not meet the statutory form, the applicant shall be informed on the spot or within five working days at a time need to correct all the contents. Late notification, from the date of receipt of the application materials shall be accepted.
(d) the application does not fall within the purview of the administrative organ, shall immediately make a decision of inadmissibility, and inform the applicant to the relevant administrative department.
Settlement of municipal drug supervision and management departments responsible for the acceptance or inadmissibility of the application for a medical device license should be issued with the special seal of the administrative organ and the date of acceptance or inadmissibility of the notice.