The Fda re-issued a letter - strengthen the mandatory industry standard management of medical devices.

TextOn July 9, the State Drug Administration issued a notice on matters related to further strengthening the management of mandatory industry standards for medical devices, and detailed the legal status, standard system, drafting and implementation of mandatory industry standards for medical devices, and detailed instructions on the implementation of norms and implementationthere is a change in the information of the drafter: the technical requirements of the mandatory industry standard sought be verifiable and operational, the preparation of mandatory industry standards should comply with the relevant provisions of the national standardization work, the foreword to the mandatory industry standards no longer contains specific drafting units and drafters information, and the drafting unit and drafter information can be reflected in the standard preparation noteson why the drafter's information is not marked in the foreword, the State Administration of Market Administration has issued an interpretation on January 17, 2020: the mandatory national standard foreword no longer labels the drafting units and drafters, is a major reform of the "mandatory national standard management measures"The main reasons forare that mandatory national standards refer to technical regulations, are not suitable for labeling drafting units and drafters, and the supreme court has clearly stated that mandatory national standards do not have copyrightfor such public goods, like other laws and regulations, should not be marked with drafting units and drafters;at the same time, in order to protect the enthusiasm of all parties to participate in standardization work, Article 40 of the Measures stipulates that after the issuance of mandatory national standards, the information of the drafting units and drafters may be queried through the national standard information public service platformto put it simply, all parties in society, including enterprises and institutions, social organizations, associations, scientific research and educational institutions, etc., participate in the formulation of mandatory national standards and there is no copyrightat the same time, in order to protect the enthusiasm of all parties involved in the development of the development and later revision and accountability supervision, the drafter information can be marked in the medical device forced industry standard noteOn the same day of, the State Drug Administration also issued yY 0485-2020 "one-time use of cardiac arrest fluid perfusion" and other 41 medical device industry standards and 2 amendments to the announcementof the 41 standards covered by this Medical Device Industry Standard Information Sheet, 14 are revised and 27 are established, three were mandatory and the remaining 38 were recommendedit's worth noting that the vast majority of standards will be implemented after June 2021 or After December 2021, and that the two standards , the basic data set for the Medical Device Unique Identification Database and the Medical Device Unique, indicate that the database filing guidelines will be implemented in October this yearas early as last year, the only coding of medical devices began to solicit opinions and continue to advancenow, medical device "ID card" written into industry standards and strictly enforced, help reduce cognitive differences in hospitals or other procurement factors, leading to the use of errors at the same time, unique marking can strictly regulate the medical equipment market, improve regulatory efficiency the establishment of a database, so that medical equipment from where, where to go, what things can be effectively traced can promote transparency in settlement, combat fraud and abuse, and further accelerate the implementation of the process of processing procurement in addition, "medical identification card" can help make the supply chain more transparent, visual, help enterprises to improve the entire product quality management system, and improve the quality evaluation standards of consumables a series of measures to be promoted by the regulatory authorities, so that medical devices from birth to circulation, to end-use, the entire process of information can be documented, to achieve medical device review and approval, clinical applications, daily supervision, medical insurance settlement and other information platform data sharing the future, it is more important for production enterprises not only to improve the quality level of production, to join the construction of information platforms, and to plan the circulation and sales strategies rationally .