Superior food and drug supervision and management departments are responsible for guiding and supervising the lower food and drug supervision and management departments to carry out supervision and management of 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 I medical devices do not require licensing and filing, the operation of Class II medical devices for the record management, the operation of Class III medical devices license management. Article Fifth, the State Food and Drug Administration to develop quality management standards for the operation of medical devices and supervise the implementation. Article 6 The food and drug supervision and management department in accordance with the law and timely release of medical device license and record information. Applicants can inquire about the progress of approval and approval results, and the public can access the results of the approval. Chapter II business license and record management Article 7 to engage in the operation of medical devices, shall have the following conditions:
(a) with the scope of business and business scale appropriate quality management institutions or quality management personnel, quality management personnel should have a nationally recognized relevant professional qualifications or titles;
(b) with the scope of business and business scale appropriate business, Storage place;
(C) with the scope of business and business scale appropriate storage conditions, all entrusted to other medical device business enterprise storage can not set up a warehouse;
(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 capacity, or agreed by the relevant organizations to provide technical support.
Enterprises engaged in the operation of Class III medical devices should also have a computerized information management system that meets the quality management requirements 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 of medical equipment business in line with the requirements of the computer information management system. Article VIII engaged in the operation of Class III medical devices, the business enterprise shall apply to the local municipal food and drug supervision and management department and submit the following information:
(a) a copy of the business license;
(b) legal representative, the person in charge of the enterprise, the person in charge of quality of the identity of the person in charge of the identity card, a copy of the certificate of academic qualifications or professional title;
(c) organization Institutions and departments set up to explain;
(D) the scope of business, business mode description;
(E) business premises, warehouse address of the geographic location of the map, floor plan, documents proving ownership of the house or a copy of the lease agreement (with documents proving the ownership of the house);
(F) the business facilities, equipment catalog;
(VII) the quality of the business management system, working procedures and other documents;
(viii) basic introduction and functional description of the computer information management system;
(ix) proof of authorization of the operator;
(x) other supporting materials. Article IX for the applicant to apply for a license for the operation of Class III medical devices, the municipal food and drug supervision and management department shall be dealt with according to the following circumstances:
(a) the application is within the scope of its competence, the application information is complete, in accordance with the statutory form, the application shall be accepted;
(b) the application information is incomplete or does not meet the statutory form, it should be On the spot or within five working days to inform the applicant of all the contents of the need to make corrections, late notification, since the date of receipt of the application information is accepted;
(c) application information can be corrected on the spot errors, the applicant should be allowed to correct on the spot;
(d) the application does not fall within the purview of the department, it should be made immediately inadmissible decisions, and Inform the applicant to apply to the relevant administrative departments.
Settlement of municipal food and drug supervision and management department acceptance or inadmissibility of the application for a medical device license, shall issue a notice of acceptance or inadmissibility. Article 10 The municipal food and drug supervision and management department shall accept the application within 30 working days from the date of review, and in accordance with the requirements of the quality management standard for the operation of medical devices to carry out on-site verification. The need for rectification, rectification time is not counted in the audit time limit.
Meet the prescribed conditions, according to law to make a written decision to grant permission, and within 10 working days to "medical device license"; does not meet the prescribed conditions, make a written decision not to permit, and the reasons. Article XI of medical devices license application directly involves the applicant and others with significant interests, the food and drug supervision and management department shall inform the applicant, the interested party in accordance with the laws, regulations and the relevant provisions of the State Food and Drug Administration to enjoy the right to apply for a hearing; in the review of the medical device license, the food and drug supervision and management department believes that involves the interests of the public ***** Significant licensing matters, should be announced to the community, and hold a hearing.