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2014 Medical Device Regulatory to "ensure safety" as the center
Release Time:2014/1/27 15:20:00

January 17, 2014 , the State Food and Drug Administration website News . According to reports , the State Food and Drug Administration Medical Device Supervision Department recently organized a medical device security to analyze the situation . The purpose is to analyze the security situation in the medical device industry , the existence of the industry to find the quality and safety risks and regulatory weaknesses , and to propose measures to strengthen the supervision and management . Reads as follows :
January 15, 2014 , the State Food and Drug Administration regulation of medical devices medical equipment company organized security situation analysis , joint analysis of the security situation in the medical device , medical device industry to find the existence of quality and safety risks and regulatory weaknesses , study and propose further strengthen supervision and management measures of medical devices .
Conferences around the production , operation, use links and adverse event monitoring , etc., seriously find the current outstanding problems exist in the medical device industry , a profound analysis of the causes of the problems , put forward proposals to further strengthen the regulatory measures . Meeting that, according to the daily supervision of medical devices , to report complaints , adverse event monitoring , risk monitoring and public opinion monitoring , etc. Last year, Chinas medical device security situation is generally stable to good, quality and safety of the annual major event does not occur , but there are also some outstanding problems and weaknesses .
The meeting stressed that in 2014 the medical device regulatory work should take " to ensure safety " as the central task , regulations and capacity building in order to focus on efforts to lay a solid foundation , strong regulations , and strengthen support and improve the system, strengthen supervision, and comprehensively promote the "Twelve five Year Plan " , the scientific use of risk management methods, explore the establishment of classification management system, strengthen supervision of high-risk products , medical equipment , carried out " five remediation "special action, vigorously promote open government and information technology , and constantly improve the quality and ability of the team to further improve the scientific level of the medical device regulatory . Meeting the requirements of food and drug supervision departments at all levels should focus on medical devices safe and effective regulatory objectives , conscientiously perform their duties , innovative ways of working to increase supervision of high-risk products , efforts to establish a sound long-term supervision mechanism , and improve various rules and regulations, building an effective technical support system and risk control system.
Experts and representatives of the country eight provinces ( city ) Council, 7 Administration Bureau and relevant departments directly under the unit , nine -related industry associations and societies, nine production enterprises and five colleges , testing and research institutions attended the meeting.
In recent years, the rising demand for medical devices in the pharmaceutical industry has a more extensive market , but due to the long-term emphasis on the use of medical institutions of imported equipment , coupled with lax oversight of the tender and other reasons , the domestic medical equipment market will inevitably disorderly phenomena . Today a news " heart stent surgery : will help still deadly " aroused great public concern. This is not only medical problems , the industry is projected to chaos .
Under the " new medical reform " policy environment , the NDRC , the Ministry of Science and other government departments on high-end medical device R & D invested a lot of special funds. Meanwhile, the state also began to strengthen supervision of the medical device industry , not only to further improve trade laws and regulations, but also to improve the scientific level of regulation of medical devices .