"Regulations for the Supervision and Administration of Medical Devices" (hereinafter referred to as "Regulations") on April 1, 2000 began to implement the supervision and management of medical devices into the legal track. Medical device standards are medical device development, production, operation, use and supervision and management *** with the technical regulations to comply with. Medical device standard work is the whole supervision and management of the technical basis of work. From the beginning of the release of the "Regulations", "medical device standards management measures" (hereinafter referred to as "measures") are included in the "Regulations" supporting regulations of the legislative program.
To address the issue of the legal status of registered product standards not given in the Regulations, we have repeatedly collaborated with the Bureau Office to report to the relevant departments, coordination, and ultimately the Trial Committee of the Supreme People's Court and the Procuratorate Committee of the Supreme People's Procuratorate adopted the "Interpretation of the Supreme People's Court and the Supreme People's Procuratorate of the Specific Application of Laws in Criminal Cases of Handling the Manufacture and Sale of Fake and Shoddy Commodities," which came into force on April 10 came into effect. In the judicial interpretation, it is clearly stipulated that "for medical devices without national standards or industry standards, the registered product standards can be regarded as 'industry standards for safeguarding human health'." Registered product standards have gained legal status. Second, the "Measures" drafting process
"Measures" discussion draft in June 2000 to complete the drafting. Successively held in February 2001, the national medical device supervision work will be held in April 2001, and held in the National Medical Device Standardization Committee Secretary General meeting to solicit comments. After June 18, 2001 held a special part of the provinces and cities and medical device quality supervision and inspection center in charge of the standard work of comrades to participate in the meeting, modify and improve, at the end of June reported to the Office of the Bureau of Regulations. According to the Division of Regulations, September 25, we reconvened the Division of Medical Devices, Medical Device Evaluation Center and acceptance of the Office to participate in the expansion of the Division will be discussed and revised the contents of the draft submitted for review, article by article, and then on October 10, together with the Office of the Bureau of comrades **** with the discussion, improve. On this basis, on October 17, Ren Secretary and personally lead the Department of Devices, Medical Device Evaluation Center, the Office of the acceptance of the draft submitted for review, article by article, the formation of the draft submitted for review, submitted to the Bureau of the Council for deliberation on November 19, 2001 by the Bureau of the Council for deliberation, in principle, adopted. Third, the important provisions of the Note
(a) "Measures" Article III provides for the categories of medical device standards, including national standards, industry standards and registered product standards, according to "two high" judicial interpretation, to clarify the legal status of registered product standards.
National standards and industry standards are not clearly defined in the Standardization Law and its related regulations. Therefore, Article 3 (a) general provisions of the "national or industry standards refers to the need to unify the technical requirements of the standard throughout the country". Article 3 (b) provides the definition of registered product standards.
(2) the current medical device standard work is not unified under the technical organization, standard development, verification by the professional standardization technical committees according to the professional division of labor. Professional Standardization Technical Committee Secretariat in the medical device testing centers. As the standard work is basic technical work, complex work, heavy tasks, and basically no economic benefits, while the testing center testing tasks are very heavy. Therefore, the work of most professional standardization and technical committees is in a state of maintenance. In order to reverse this passive situation, Article 6 of the Measures stipulates that the Drug Administration under the State Council shall set up a technical committee for medical device standardization and shall be responsible for the research, technical guidance and coordination of the national medical device standardization work under its direct leadership. The secretariat of the technical committee is to be located in the Medical Device Technical Review Center.
(3) The national standardization work has been supervised by the national standardization department, due to historical reasons, the standard work of medical devices has also been carried out under their unified management. Although the professional standardization technical committees of medical devices are under the management of the competent department of medical devices, the establishment and renewal of the competent department of national standardization are subject to the approval of the competent department of national standardization, and the participation in international standardization activities is also required to go through them. Therefore, Article 7 of the Measures to clarify the tasks of the medical device professional standardization technical committees, expressed as "the main tasks of the state set up a professional standardization technical committees of medical devices is", and no longer specify who set up. In addition, the management of the professional standardization technical committee has a "national professional standardization technical committee charter", so the "measures" does not involve this part of the content.
(4) Regarding the formulation and release of national and industrial standards, there are special Measures for the Administration of National Standards and Measures for the Administration of Industrial Standards. The Measures can not be repeated one by one, but the national standards for medical devices and industry standards is an important part of the medical device standards, the Measures can not be completely omitted from this part of the content, so in Chapter III to make a brief provision.
According to the division of functions of the State Council, the development and revision of national standards by the National Standardization Administration Committee unified review, approval, numbering, release. The original draft for review of the national standards for medical devices to develop the main body, the development of procedures and status, etc. have been stipulated. In accordance with the opinion of the Department of Regulations that it is not appropriate to refer to other administrative departments in departmental regulations, we have deleted the content of the original draft that involves the national standardization authority.
(E) in order to strengthen the work of registered product standards, "Measures" Article XIII provides for the development of "medical device registered product standards preparation norms", Article 14 and Article 16 of the registered product standards should include the content of the preparation of the content and the initial review and review of the main content of the registered product standards were specified.
(F) measures Article 8 (3) provides that "provinces, autonomous regions and municipalities directly under the Central Drug Administration is responsible for the production of medical devices within the jurisdiction of the review of the registered product standards and standards for the registration of Class III medical devices product standards for the first review. Among them, the provinces, autonomous regions, drug supervision and management departments are responsible for the jurisdiction of the production of the second class of medical devices registered product standards review and the third class of medical devices registered product standards for the initial examination. Municipalities directly under the Central Drug Administration is responsible for the jurisdiction of the production of the first and second class of medical devices registered product standards for the review and third class of medical devices registered product standards for the preliminary examination.