Article 5 The Drug Administration under the State Council to perform the following duties:
(1) organization and implementation of medical device standards work laws and regulations, the development of medical device standards work guidelines, policies and management methods;
(2) organization to formulate and implement the work of medical device standards planning and planning. Guidance, supervision of the national medical device standards work;
(c) organization of drafting national standards for medical devices. Organize the development and release of medical device industry standards. According to the national standards and industry standards for the relevant requirements of the review of imported medical devices and registered product standards and domestic production of Class III medical devices registered product standards;
(d) supervise the implementation of medical device standards;
(e) management of medical devices professional standardization and technical committees;
(f) organization of the conversion of international standards, and carry out exchanges of foreign standard work;
(vii) responsible for medical device standard work recognition and rewards. Management of standard work funds.
Article 6 The Drug Administration under the State Council to establish a medical device standardization technical committee, responsible for the national medical device standardization work of technical guidance and coordination, to perform the following duties:
(1) to carry out research on medical device standard system, put forward the medical device standard work policy and standard project planning recommendations;
(2) commissioned by the Drug Administration under the State Council, review and approve the medical device standard work of the medical device standard work of the medical device standard work of the medical device standard work of the medical device standard work of the drug administration under the State Council. Supervision and Administration of the State Council commissioned by the national standards for medical devices, industry standards, review of imported medical devices registered product standards and domestic production of Class III medical devices registered product standards;
(c) guidance, coordination of the work of the professional standardization of medical devices technical committees;
(d) to carry out standards training, publicity, technical guidance and domestic and foreign standardization of academic exchanges;
(e) to provide medical device standards, standards and standards of medical devices; and Academic exchange activities;
(v) inform the medical device standards work information.
Article VII of the state established the main tasks of the medical device professional standardization technical committee is:
(1) publicity and implementation of standardization laws, regulations, guidelines and policies;
(2) put forward the medical device national standards of various professions or industry standards development, revision and research project planning and planning recommendations. To carry out research on medical device standards;
(c) undertake the task of formulating and revising national standards and industry standards, and be responsible for the collation, proofreading and editing of the standards submitted for approval;
(d) undertake the technical guidance of the work of medical device standards. To assist the drug supervision and management departments at all levels to deal with technical problems in the implementation of standards;
(e) responsible for collecting and organizing medical device standard information, the establishment of medical device standards within the profession of technical archives;
(f) carry out the national standards for medical devices, industry standards for the publicity and implementation of academic exchanges, and assist in the training of standards staff.
Article VIII Provinces, autonomous regions, municipalities directly under the Central Drug Administration in the administrative region to perform the following duties:
(a) the implementation of medical device standards of laws, regulations, guidelines and policies;
(b) in the administrative region to supervise the implementation of medical device standards;
(c) is responsible for the jurisdiction of the production of medical devices registered product standard The review and Class III medical device registered product standards of the preliminary examination;
(d) guidance and coordination of entrusted to undertake the drafting of national standards, industry standards.
Article IX municipal drug supervision and management department is responsible for the administrative region of the first class of medical devices registered product standards review.
The municipal and county (city) drug supervision and management department is responsible for the administrative region of the implementation of medical device standards supervision and inspection work.