By the end of 2019, 89.4% of the revised medical device standard system has been completed

Medical Network July 13 - July 8, the State Drug Administration released the "China Medical Device Standards Management Annual Report (2019)" shows that by the end of 2019, the "13th Five-Year Plan" 500 medical device standards revision tasks have been set up 447, has been completed 89.4%the above annual report shows that in 2019, a total of 5 national standards, 72 industry standards and industry standard modification s3, a total of 1671 medical device standards, medical device standards technology system continued to optimizeby the end of 2019, there are 273 basic standards, 54 management standards, 406 method standards and 938 product standards in the current effective medical device standardsAccording to the Chinese Standard Document classification law, medical device standards are mainly classified between C30 and C49, C10 and C30 represent medicine and medical device synthesis, other code names refer to the field of specific productsfrom the existing medical device standard area distribution, the top 5 are: medical laboratory equipment (C44) 13.8%, general and microsurgical instruments (C31) 11.6%, orthopaedic, orthopaedic equipment (C35) 10.8%, oral instruments, equipment and materials (C33) 9.8%, medical radiation equipment (C43) 9.1%according to the standard committee (technical return unit) in the field, the number of standards in the top 5 are: medical electrical equipment 339 (20.3%), in vitro diagnostics 243 (14.5%), surgical implants 209 (12.5%), oral materials and instruments 163 (9.8%) and infusion equipment 148 (8.9%)in the various areas of the mouth, according to the different areas of the standard needs, the standard categories are different, medical electrical equipment, respiratory anesthesia in the field of basic standards accounted for a relatively high, both up to 29.0%the highest proportion of management standards in the field of medical device standard management and quality management, at 100% and 85.7%, respectivelythe highest proportion of methodological standards in the field of medical device biology evaluation, at 90.2%the highest proportion of product standards in the field of family planning and in vitro diagnostic medical devices, at 86.2% and 86.0%, respectivelythe technical support of medical device standards in the above-mentioned annual report shows that the standard committee (technical unit) is the medical device standard system revision of the main body, but also an important part of the structure of the medical device standard systemsince the establishment of the first Technical Committee on The Standardization of Medical Devices in 1980, after 40 years of development, the number of standard committees (technical units) has gradually increased to 32 (13 General Technical Committees, 13 Sub-Technical Committees and 6 technical units)the field of medical device standards work continues to expand, medical device standards organization structure to further improve, is conducive to give full play to the new situation of medical device standards leading role and technical support rolein addition, the relevant departments also timely increase the intensity of standard information disclosure, improve standard accessibility, the State Drug Administration Medical Device Standards Management Center website published the standard text of medical devices, to achieve the medical device industry standard catalog and mandatory medical device industry standard text 100% public2019, the first batch of 636 non-standard recommended medical device industry standard text, non-standard recommendation industry standard text to the public open rate of 87%at the same time, we will continue to strengthen the disclosure of information on the standard system revision, improve the participation of standards, continue to expand the public disclosure of the information of the revision process of the standard system through information technology, ensure the transparency and openness of the revision of the standard system, and enhance the participation of all partiesinclude expanding the source of standard projects, soliciting standard opinions widely, and exploring standard feedback mechanisms .