The State Drug Administration issued a letter, the medical device industry will be strictly controlled

on June 15, the State Drug Administration issued the "Notice of the General Department of the State Drug Administration on matters related to further doing a good job in the investigation and prosecution of cases." Deploy to further do a good job in the investigation and prosecution of medical device violations, crack down on illegal and illegal activities, and effectively strengthen drug safety supervisionAccording to the requirements, drug regulatory departments at all levels should further implement the regulatory power, do a good job of inspection and inspection work convergence, timely fix evidence of suspected illegal acts, strengthen cooperation with relevant departments, strengthen the implementation of administrative punishment decisions, strictly implement the "punishment to people" provisions, do a good job in the prevention and control of major cases of risk, and strengthen the case investigation and prosecution supporting protectionin fact, the safety of medical devices is related to the health and safety of the people, in recent years, the state has been increasing drug supervision, the supervision and management of medical devices is gradually tighteningThe implementation of the 2000 edition of the Regulations on the Supervision and Administration of Medical Devices and the revision of the 2006 Regulations on The Supervision and Administration of Medical Devices (2000) have played a good and positive role in the development of the entire medical device industryBut with the rapid rise of the development level of the medical device industry, the content of relevant regulations is not perfect, the system coordination is not high enough, the legislation is not strong enough, and the punishment deterrence is not strong enough and so onIn order to meet the development of the industry, the state has issued a series of documents in recent years to further improve the field of medical devices supervisionsuch as the former State Food and Drug Administration in July 2015 formulated and issued the "On the issue of medical device production quality management norms appendix aseptic medical device announcement", "on the issuance of medical device production quality management norms implantable medical device announcement", "on the issuance of medical device production quality management norms in vitro diagnostic reagents announcement."promulgated and issued the Guide to Quality Management of Water for Medical Device Process in 2016, and in December of the same year, it issued the Guide to Quality Control and Release of Finished Products of Medical Device Manufacturers to guide medical device manufacturers to control the procurement of raw materials, production processes and quality inspection in accordance with the technical requirements of the products that have been registered or filedit is worth noting that on March 27, 2020, the State Drug Administration held a nationwide teleconference on medical device supervision and management, which deployed the key work of medical device supervision in 2020Among them, it is clearly proposed to speed up the supervision of the rule of law system and capacity-building, accelerate the review and approval system and capacity-building, accelerate the risk prevention and control system and capacity-building, accelerate the technical support system and capacity-building, accelerate the social management system and capacity-buildingon this, the industry believes that in order to promote the healthy and orderly development of the medical device industry, the national medical device sane sector of all links, all channels have been adequately deployedIn the future, with more industry standards to be revised and improved, the domestic medical device industry will be more conducive to the development of standardization, standardization, high-quality directionFor enterprises and medical institutions, more cautious treatment of medical devices will become an inevitable trendFor example, in the research and innovation of medical devices, we need to follow the principles of safety, effectiveness and economy more.