Medical device registrants, filers of listed medical devices are responsible for the safety and effectiveness. Article IV according to the degree of risk of medical devices, medical device production implementation of classification management.
Engaged in the second, third class medical device production activities, should be approved by the local provincial, autonomous regions and municipalities directly under the Central Drug Administration, according to law to obtain a medical device production license; engaged in the production of Class I medical devices, should be located in the municipal drug supervision and management department responsible for the production of medical devices for the record. Article 5 The State Drug Administration is responsible for the supervision and management of the national medical device production.
Provinces, autonomous regions, municipalities directly under the Central Drug Administration is responsible for the administrative region of the second class, the third class of medical devices production supervision and management, in accordance with the responsibilities of the administrative region is responsible for the supervision and management of the production of Class I medical devices, and to strengthen the supervision and management of the production of Class I medical devices of the administrative region of the supervision and management work.
Settlement of municipal drug supervision and management departments in accordance with the responsibilities of supervision and management of the administrative region in accordance with the responsibilities of the first class of medical device production activities. Article drug supervision and management departments set up or designated by law, medical device review, inspection, testing, monitoring and evaluation and other professional and technical institutions, in accordance with the division of responsibilities to undertake the relevant technical work for the supervision and management of the production of medical devices to provide technical support.
The State Drug Administration Food and Drug Administration Audit and Inspection Center for the development of medical device inspection system and technical documents, to undertake major cause of inspection and overseas inspection, and provinces, autonomous regions and municipalities directly under the Central Government of the quality management system of medical device inspection institutions for guidance and assessment. Article 7 The State Drug Administration to strengthen the supervision and management of medical device production 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 production supervision and management of information technology construction and management, in accordance with the requirements of the State Drug Administration to promote the supervision and management of medical device production information **** enjoy. Article VIII drug supervision and management departments in accordance with the law timely disclosure of medical device production license, filing, supervision and inspection, administrative penalties and other information to facilitate public inquiry, accept social supervision. Chapter II production license and record management Article IX engaged in the production of medical devices, shall have the following conditions:
(a) with the production of medical devices and the production of appropriate production sites, environmental conditions, production equipment and professional and technical personnel;
(b) the production of medical devices to carry out quality inspection of the institution or full-time inspectors and inspection equipment;
(c) ensure that medical devices, medical devices, medical devices, medical devices, medical devices, medical devices, medical devices, medical devices, medical devices and other medical equipment. p>(C) have to ensure that 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 10 in the territory engaged in the production of Class II, Class III medical devices, shall apply to the local provinces, autonomous regions and municipalities directly under the Central Drug Administration for production authorization, and submit the following materials:
(a) the production of medical devices and product registration certificate and a copy of the technical requirements of the product;
(b) legal representative (person in charge of the enterprise) a copy of the identity card;
(C) production, quality and technical personnel in charge of the identity, education, title copies of relevant materials;
(D) production management, quality inspection positions of practitioners education, title list;
(E) copies of the relevant documents of the production site, there are special requirements for the production environment, but also should be submitted to the facilities, the environment of the relevant documents copies;
(F) Catalog of main production equipment and inspection equipment;
(vii) Catalog of quality manuals and procedural documents;
(viii) Diagram of production process;
(ix) Relevant materials proving after-sales service capability;
(x) Authorization documents of the operator.
The applicant shall ensure that the submitted materials are legal, true, accurate, complete and traceable.
Related materials can be verified through the network, without the applicant to provide. Article XI of the provinces, autonomous regions and municipalities directly under the Central Drug Administration received an application, shall be processed in accordance with the following circumstances:
(a) the application matters belong to the administrative organs within the purview of the application information is complete, in accordance with the statutory form, the application shall be accepted;
(b) the application information can be corrected on the spot, the applicant shall be allowed to correct the error;
(c) the applicant shall ensure that the materials submitted are true, accurate and traceable through the network verification. /p>
(c) the application information is incomplete or does not meet the statutory form, the applicant shall be notified on the spot or within five working days at a time of the need to make corrections to all the contents of the late notification, from the date of receipt of the application information shall be accepted;
(d) the application does not fall within the purview of the administrative organ, it shall be immediate inadmissibility of the decision, and inform the applicant to the (d) The application does not fall within the scope of this administrative organ, and inform the applicant to apply to the relevant administrative organ.
Provinces, autonomous regions, municipalities directly under the Central Drug Administration to accept or reject the application for authorization of the production of medical devices, should be issued with the special seal of the administrative organ and the date of acceptance or notification of inadmissibility.