To protect human health and safety of life technical requirements, should be developed into mandatory national standards for medical devices and mandatory industry standards.
To meet the basic general, with mandatory standards, the medical device industry to play a leading role in the need for technical requirements, can be developed into recommended national standards for medical devices and recommended industry standards. Article V medical device standards in accordance with its normative object is divided into basic standards, methodology standards, management standards and product standards. Article 6 The State Food and Drug Administration in accordance with the preparation of medical device standards planning, the establishment of medical device standards management system, improve the medical device standards management system. Article 7 encourages enterprises, social organizations, educational and scientific research institutions and individuals to participate in medical device standards revision work, and supervision of the implementation of medical device standards. Article 8 encourage participation in international standardization activities, participate in the development and adoption of international medical device standards. Article IX of the State Food and Drug Administration of the medical device standards in the work of organizations and individuals who have made significant achievements, in accordance with relevant state regulations to give praise and reward. Chapter II standard management responsibilities Article 10 The State Food and Drug Administration to perform the following duties:
(a) organization and implementation of medical device standards management related laws and regulations, the development of medical device standards management system;
(b) organization of the formulation of medical device standards planning, the preparation of standards revision of the annual work plan;
(c) according to law to organize Medical device standards revision, release of medical device industry standards;
(4) according to law to guide, supervise the management of medical device standards. Article XI of the State Food and Drug Administration Medical Devices Standards Administration Center (hereinafter referred to as "Medical Devices Standards Administration Center") to perform the following duties:
(a) to organize and carry out research on medical device standards system, to develop a draft plan for the standard of medical devices and standard revision of the annual work plan proposal;
(2) to undertake the management of medical device standards revision;
(3) to undertake the management of medical device standardization technical committees;
(4) to undertake the standard of medical devices publicity, training and organization;
(5) organization of the standard implementation of research, coordination and resolution of major technical problems in the implementation of standards;
(F) undertake international standardization of medical devices and foreign cooperation and exchanges of relevant work;
(G) undertake medical device standard information technology, medical device industry standard publication;
(H) undertake the State Food and Drug Administration of the other standards management work assigned. Article XII of the State Food and Drug Administration in accordance with the needs of medical device standardization, the approval of the formation of medical device standardization technical committees.
Technical Committee for the Standardization of Medical Devices to perform the following duties:
(a) to carry out research on medical device standards, put forward the professional field of standards development planning, standards system comments;
(b) undertake the professional field of medical device standards drafting, consultation, technical review and other organizational work, and the technical content of the standard and the quality of responsibility;
(C) to undertake the professional field of medical device standards of technical guidance, to help solve technical problems in the implementation of standards;
(D) responsible for the collection and collation of medical device standards in this field of medical information, and the establishment of technical files;
(E) responsible for the implementation of this professional field of medical device standards tracking and evaluation;
(F) is responsible for the professional field of medical device standards of technical content consultation;
(F) responsible for the professional field of medical device standards of technical content consultation. (F) is responsible for the field of medical device standard technical content of the consultation and interpretation;
(VII) undertake the professional field of medical device standard publicity, training, academic exchanges and related international standardization activities. Article XIII in the existing technical committee for the standardization of medical devices can not cover the professional and technical fields, the State Food and Drug Administration can be based on regulatory needs, in accordance with the procedures for determining the standardization of medical devices technical focal point. Standardization of technical reporting unit with reference to the responsibilities of the Medical Devices Standardization Technical Committee and the relevant provisions of the corresponding areas of medical device standards. Article 14 The local food and drug supervision and management departments in the administrative region to perform the following duties:
(a) organization and implementation of medical device standards management laws and regulations;
(b) organization, participation in the formulation and revision of medical device standards related to the work;
(c) supervision of the implementation of medical device standards;
(d) collect and report on the implementation process of standards to the next level Food and Drug Administration to report on the implementation of standards in the process of problems.