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Nationwide announcement: inspection results of medical device quality and safety risks

Issuing time:2021-07-05 17:23

In March this year, the State Food and Drug Administration issued the "Notice on Carrying out the Inspection and Management of Medical Device Quality and Safety Risks", deploying the inspection and management of medical device quality and safety risks, sorting out epidemic prevention and control medical devices, and centralized procurement. Nine categories of products and enterprises, including selected products, are the focus of risk investigation and management.



  As of June 25, all provinces (autonomous regions and municipalities) have further promoted the investigation and management of hidden dangers in the quality and safety of medical devices as follows:



   Hainan



On April 2, Hainan Provincial Food and Drug Administration issued the "Notice on Carrying out the Inspection and Management of Medical Device Quality and Safety Risks", in accordance with the unified deployment of the State Food and Drug Administration, and the actual situation of the province, actively carried out the inspection and management of medical device quality and safety risks. jobs.



   On June 22, the Hainan Provincial Food and Drug Administration fully promoted the investigation and management of medical device quality and safety risks, focused on strengthening the level of medical device risk management, and enhancing the quality and safety awareness of medical device practitioners.



Up to now, the Hainan Provincial Food and Drug Administration has inspected 28 medical device manufacturers, found 155 defective items, ordered 3 companies to suspend production for rectification; inspected 553 operating companies and 258 users, ordered 6 rectifications and filed cases Investigated and dealt with 4 companies that violated laws and regulations; inspected 122 medical device online sales companies and 18 third-party online transaction service platforms; conducted legal training for more than 760 person-times.



   Shanxi



On April 7, the Shanxi Provincial Drug Administration issued a notice to deploy the province-wide investigation and management of medical device quality and safety risks, strengthen medical device risk management, improve the quality and safety assurance level of medical devices, and promote the high quality of the medical device industry development of.



On June 10, the Shanxi Provincial Food and Drug Administration held a medical device risk research and judgment meeting in the second quarter of this year, to report the results of the first quarter risk consultation, to study and discuss the quality and safety risks of medical devices in the second quarter, and to study and discuss the State Drug Administration Implementation measures of the Bureau and the National Standardization Committee "Opinions on Further Promoting the High-quality Development of Medical Device Standardization Work".



   Heilongjiang



On April 13, the Heilongjiang Provincial Food and Drug Administration issued the "Notice on Carrying out the Investigation and Governance of the Province's Medical Device Quality and Safety Risks", focusing on epidemic prevention and control medical devices, selected products in centralized procurement, sterility and implantation Investigation and management of sexual medical devices and other aspects.



From May 25 to 27, in order to strengthen medical device risk management, further improve the quality and safety assurance level, and promote the high-quality development of the medical device industry in Heilongjiang Province, according to the State Food and Drug Administration's medical device quality and safety risk investigation and management work and strengthen one-time use As for the inspection of sterile syringes, the Medical Devices Division of the Heilongjiang Provincial Food and Drug Administration conducted a comprehensive risk investigation on Heilongjiang Shenghua Medical Devices Co., Ltd., a large infusion company in Heilongjiang Province.



  Ningxia



On April 13, the Ningxia Hui Autonomous Region Food and Drug Administration issued the "Regarding the supervision and inspection of the operation and use of medical devices in the region in 2021 and the investigation and management of hidden risks of quality and safety in accordance with the deployment requirements of the State Food and Drug Administration in combination with local conditions." "Notice" to fully promote the investigation and management of hidden dangers.



   On May 31, the Drug Administration of Ningxia Hui Autonomous Region formulated the "Ningxia Hui Autonomous Region Medical Device Risk Consultation Mechanism (Trial)" after in-depth investigations to further improve the accuracy of supervision and effectively improve the quality and safety of medical devices in the region.



   Anhui



   On April 15, the Anhui Provincial Food and Drug Administration organized and held the first quarter of 2021 medical device quality and safety risk analysis and judgment meeting. The meeting pointed out that in accordance with the requirements of the "Notice of the Anhui Provincial Drug Administration on Carrying out the Inspection and Management of Medical Device Quality and Safety Risks", we will strengthen the inspection and management of hidden risks, effectively prevent and resolve risks, and improve the quality and safety of medical devices.



   On May 26, the Anhui Provincial Food and Drug Administration organized a meeting to promote the investigation and management of medical device quality and safety risks.



   Tibet



   On April 15, the Tibet Autonomous Region Food and Drug Administration issued the "Notice on Carrying out the Inspection and Treatment of the Hidden Risks of Medical Device Quality and Safety in the Region", which is scheduled to carry out the inspection and management of the hidden risks of medical devices in the region from April to October.



On May 12, the Tibet Autonomous Region Food and Drug Administration released the results of the first quarter of the Tibet Autonomous Region's medical device risk investigation and management work. A total of 1 medical device production unit, 352 business units, 387 use units, and 2 online sales units were investigated. , To investigate and eliminate 54 hidden risks such as operating medical devices with incomplete licenses, using unqualified medical devices, and changing business premises and warehouses without authorization.



  Guangdong



   On April 16, the Guangdong Provincial Food and Drug Administration issued the "Notice on Doing a Good Job in Examining and Managing Medical Device Quality and Safety Risks", requiring the strengthening of risk management in the production, operation and use of medical devices and further improving the level of quality and safety assurance.



   Fujian



   On April 21, the Fujian Provincial Food and Drug Administration issued the "2021 Medical Device Quality and Safety Risks Inspection and Management Work Plan."



  Beijing



On April 22, the Beijing Municipal Food and Drug Administration organized the city's key work on drug and medical device supervision and the deployment meeting for the inspection of hidden risks in the quality and safety of medical devices to strengthen risk management, improve the quality and safety assurance level of Beijing's drug and medical devices, and promote the high-quality development of the pharmaceutical industry .



   Jiangsu



   On April 23, the Jiangsu Provincial Food and Drug Administration launched the inspection and management of hidden dangers in the quality and safety of medical device production and operation, and through comprehensive inspection of hidden risks, it urged enterprises to implement the main responsibility for quality and safety and improve the level of quality management.



On June 23, the Jiangsu Provincial Food and Drug Administration organized and transferred 64 inspectors to conduct cross-flying inspections of 34 medical device manufacturers in Jiangsu Province. According to the inspection results, they held a briefing for inspection team leaders and conducted special risk consultations. .



   Qinghai



On April 23, Qinghai Provincial Food and Drug Administration issued the "Notice on Carrying out the Inspection and Governance of Medical Device Quality and Safety Risks", making arrangements and requirements for Qinghai Province to strengthen the safety supervision of medical devices, and striving to achieve a comprehensive investigation and management of potential risks. Fully implement the work objectives of comprehensively improving the management level and comprehensively strengthening quality assurance.



On June 25, in accordance with the work arrangements and related requirements of the Qinghai Provincial Drug Administration Party Group on the supervision of "two products and one device" and safe production, the Medical Device Supervision Department of Qinghai Drug Administration adopted a combination of enterprise self-inspection and on-site inspection In this way, an inspection team was formed to conduct on-site safety inspections of medical device manufacturers in the province.



  As of June 22, the inspection team had inspected 10 enterprises on site, and 13 enterprises were self-inspected, achieving full coverage of safety inspections.



   Jiangxi



   On April 25, the Jiangxi Provincial Food and Drug Administration issued the "Notice on Printing and Distributing the Work Plan for the Inspection and Management of Hidden Risks in Medical Device Quality and Safety Risks in Jiangxi Province", requesting a large-scale investigation and management of hidden risks in the quality and safety of medical devices.



   On May 20, the Jiangxi Provincial Food and Drug Administration issued the "Notice on Holding Jiangxi Province Medical Device Supervision and Administration Regulations Propaganda and Implementation Training Course and Medical Device Quality and Safety Risk Investigation and Management Work Promotion Meeting".



   On May 28, the Jiangxi Provincial Food and Drug Administration organized a promotion meeting for the investigation and management of medical device quality and safety risks in Jiujiang. At the meeting, the Jiangxi Provincial Food and Drug Administration notified the state of the province’s new crown virus detection reagent supervision and inspection, risk hazard investigation and management, medical device online sales supervision and other key medical device supervision work developments, and concentrated discussions on the occurrence of risk hazards in the early stage. The risk points and the problems encountered in the investigation, and the next step is to do a good job in the investigation and management of the hidden dangers of the quality and safety of medical devices.



   Inner Mongolia



   On April 26, the Drug Administration of Inner Mongolia Autonomous Region organized a regional medical device regulatory risk consultation meeting in the first quarter of 2021 to report on risk monitoring, analyze and judge the severity and possible harms, and study and formulate treatment measures.



   Shandong



   On April 26, the Shandong Provincial Food and Drug Administration issued a notice to intensively carry out the investigation and remediation of illegal medical device operations in the province, and promote the investigation and management of hidden risks in the business link.



   From May 27th to June 4th, the "Shandong Drug Supervision" WeChat official account released the investigation and rectification trends of medical device business violations carried out in various parts of the province.



   Henan



   On April 26, the Henan Provincial Food and Drug Administration issued the "Medical Device Quality and Safety Risk Hidden Risks Inspection and Governance Work Plan", which made arrangements and put forward requirements for strengthening medical device risk supervision.



  Guangxi



On April 26, the Drug Administration of Guangxi Zhuang Autonomous Region held a post-marketing regulatory risk conference for medical devices in the second quarter of 2021 in Nanning. The meeting sorted out the hidden quality risks of medical devices found in the first quarter of inspection and supervision, and analyzed and judged the medical devices. Supervise the causes of risks, and focus on studying effective methods to prevent and control different types of risks, and deploy the next step of risk prevention.



   Hubei



On April 27, the Hubei Provincial Food and Drug Administration announced the Hubei Provincial Medical Device Quality and Safety Risks Inspection and Management Work Plan, requiring drug regulatory agencies at all levels across the province to adopt cross-inspection, joint inspection, entrusted inspection, follow-up inspection, third-party assessment, "Internet + supervision" and other forms of investigation and governance are carried out, and key enterprises are "looked back". At the same time, it is necessary to seriously investigate and deal with violations of laws and regulations, and strengthen exemplary demonstration and guidance.



   Gansu



   On April 28, the Gansu Provincial Food and Drug Administration organized some municipal and prefecture market supervision departments to convene the first quarter medical device quality and safety risk consultation meeting. At the meeting, the heads of the medical device supervision work of the market supervision bureaus of Lanzhou, Wuwei, Baiyin, Lanzhou New District, etc. arranged arrangements for the investigation and management of hidden risks of medical device quality and safety risks, and promoted comprehensive self-inspection of enterprises, and how to carry out the quality of medical devices. Specific and feasible opinions and suggestions were put forward for the investigation of hidden dangers of safety risks.



   Shaanxi



   On April 30, the Shaanxi Provincial Food and Drug Administration issued a notice to comprehensively deploy the investigation and management of hidden risks of medical devices, strengthen the risk management of medical devices, improve the quality and safety assurance level, and ensure the safety of the public in using equipment.



   On June 4, Shaanxi Province held a regular meeting of medical device risk consultation in the second quarter of 2021. The meeting focused on 8 issues such as supervision and inspection, quality supervision and random inspection, adverse event monitoring, online transaction monitoring, complaint report handling, public opinion monitoring, investigation of violations of laws and regulations, and product recalls, and discussed the risk prevention and control measures determined by the first quarter risk consultation meeting Implementation, in-depth analysis of the current medical device regulatory safety risk situation, comprehensive research and judgment on risk changes and new risk information, and proposed to accelerate the construction of an "integrated" pattern of comprehensive risk management systems in provinces, cities and counties, and improve risk management capabilities.



   Xinjiang



   On May 10, the Drug Administration of Xinjiang Uygur Autonomous Region held a seminar on medical device quality and safety risk investigation based on four phases of training courses on medical device laws and regulations in Urumqi and Turpan.



   Jilin



   On May 13, the Jilin Provincial Food and Drug Administration launched the first quarter medical device risk consultation work, and carried out rectifications one by one according to the risk clues in order to eliminate hidden risks.



   On May 14, the Jilin Provincial Food and Drug Administration organized a joint meeting of the province's medical device risk consultation.



   On May 18, the Jilin Provincial Food and Drug Administration issued a notice to comprehensively carry out the supervision and management of medical device operation and use, as well as the inspection and management of quality and safety risks, further improve the level of quality and safety assurance, and promote the high-quality development of the medical device industry in Jilin Province.



  Zhejiang



   On May 13, Zhejiang Food and Drug Administration, in accordance with the relevant requirements of the State Food and Drug Administration on the investigation and management of hidden risks of medical device quality and safety, made precise deployment and solid progress, and made every effort to improve the effectiveness of Zhejiang medical device risk management.



   Chongqing



   On May 18, the Chongqing Drug Administration issued a notice to deploy the city to comprehensively promote the investigation and management of hidden dangers in the quality and safety of medical devices. The notice clarified that carrying out this risk investigation and management work must strengthen the risk management of medical devices, further improve the quality and safety assurance level, effectively prevent and resolve safety risks, and promote the high-quality development of the medical device industry.



   Yunnan



   On May 31, the Yunnan Provincial Food and Drug Administration issued a notice to deploy the investigation and management of hidden dangers in the quality and safety of medical devices.



  Shanghai



   From June 7th to 11th, Shanghai Municipal Drug Administration organized the 2021 Medical Device Inspector Training and Risk Inspection and Governance Special Unmanned Inspection Mobilization Meeting. The meeting emphasized that it is necessary to conscientiously implement the work requirements of the municipal government and the requirements of the State Food and Drug Administration's risk inspection and management notice, and earnestly do a good job in the three key tasks of medical device risk investigation and management, risk consultation and regulation, and firmly maintain the bottom line of product safety. Ensure the safety of the people's use of machinery.



  Sichuan



   The Sichuan Provincial Food and Drug Administration organized the first quarter medical device quality and safety supervision risk consultation meeting. The meeting summarized the investigation and management of hidden risks of medical devices in the first quarter, and analyzed and evaluated the risk points of 142 production links.



   Tianjin



   The Tianjin Medical and Drug Administration organized a consultation meeting on the regulatory risks of medical device production in the second quarter of 2021. The meeting determined that the "flame resistance" index control of medical protective clothing products was the main risk point, and listened to the control methods and expected effects of the "flame resistance" indicators adopted by representatives of various manufacturers. Based on the company's in-depth research on "flame resistance" indicators and inadequate control, the meeting gave suggestions for risk prevention and control, that is, implementing hierarchical management of products, distinguishing specifications and models according to product usage scenarios, and clearly indicating in the instructions and labels.



   Liaoning



   In the process of organizing and carrying out the inspection and management of medical device quality and safety risks, the Liaoning Provincial Food and Drug Administration has combined with the implementation of the "Regulations on the Supervision and Administration of Medical Devices" to strengthen the investigation and inspection of production and operation enterprises and users.



Up to now, the municipal bureaus and inspection offices have investigated 104 sterile implantable medical device manufacturers, and 112 hidden risks have been identified, 106 hidden risks have been eliminated; 2,983 operating companies have been investigated, 19 hidden risks have been identified, and risks have been eliminated There were 19 hidden dangers, 9 cases were filed, 13 companies were warned, 26 companies were ordered to rectify; 2,468 users were investigated, 27 hidden risks were detected, 27 hidden risks were eliminated, 10 companies were warned, and 25 companies were ordered to rectify.



  Hebei



The Hebei Provincial Food and Drug Administration is actively carrying out the investigation and management of medical device quality and safety risks, focusing on 9 aspects including epidemic prevention and control medical devices, centralized procurement of selected products, sterile and implantable medical devices, and online sales of medical devices. Focus on investigation. Since May, a total of 984 hidden risks have been identified, 959 hidden risks have been eliminated, and 11 long-term mechanisms have been established.



  Guizhou



In order to further strengthen the supervision of the quality of medical device products in Guizhou Province and effectively maintain market order, in accordance with the requirements of the "Notice on Carrying out the Inspection and Governance of Hidden Risks in the Quality and Safety of Medical Devices in Guizhou Province", the Guizhou Provincial Food and Drug Administration has imposed a strict Carried out the flight

an examination.



  Hunan



The Hunan Provincial Food and Drug Administration has formulated the "Hunan Province 2021 Medical Device Quality and Safety Risk Inspection and Governance Work Plan" based on the main points of the province’s medical device supervision work and the "two products and one device" supervision and inspection plan, clarifying the work objectives, principles, arrangements and Requirements, determine the focus of investigation and governance, and comprehensively sort out the hidden dangers of the investigation.



In May of this year, the Hunan Provincial Food and Drug Administration organized a first quarter medical device quality and safety risk conference to study and discuss the quality and safety risks of medical devices in the province, and based on the risk consultation opinions, ranked the top ten adverse event reports and risks The 13 relatively high medical device manufacturers sent letters to urge them to take effective measures to prevent and control risks. As of June 8, a total of 7,827 medical device manufacturers and users have been investigated, 595 hidden risks have been investigated, 579 hidden risks have been eliminated, and 56 long-term mechanisms have been established.


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