Medical network, July 1 - in March this year, the State Food and Drug Administration issued the notice on carrying out the investigation and treatment of potential quality and safety risks of medical devices, deployed the investigation and treatment of potential quality and safety risks of medical devices, and sorted out 9 categories of products and enterprises such as epidemic prevention and control medical devices and centralized procurement of selected products as the focus of risk investigation and treatment.
As of June 25, the provinces (autonomous regions and municipalities) have further promoted the investigation and treatment of potential risks in the quality and safety of medical devices, as follows:
Hainan
On April 2, Hainan Food and Drug Administration issued the notice on the investigation and treatment of potential quality and safety risks of medical devices, which actively carried out the investigation and treatment of potential quality and safety risks of medical devices in accordance with the unified deployment of the State Food and Drug Administration and in combination with the actual situation of the province.
On June 22, Hainan Food and drug administration made every effort to promote the investigation and treatment of potential risks in the quality and safety of medical devices, strive to strengthen the risk management level of medical devices and enhance the quality and safety awareness of medical device practitioners.
Up to now, Hainan Food and drug administration has inspected 28 medical device manufacturers, found 155 defects, and ordered 3 enterprises to stop production for rectification; 553 operating enterprises and 258 using units were inspected, 6 were ordered to rectify, and 4 enterprises in violation of laws and regulations were filed for investigation and punishment; 122 medical device online sales enterprises and 18 third-party platforms for online trading services were inspected; More than 760 people received training on laws and regulations.
Shanxi
On April 7, Shanxi food and Drug Administration issued a notice, which deployed to carry out the investigation and treatment of potential quality and safety risks of medical devices throughout the province, strengthen the risk management of medical devices, improve the quality and safety guarantee level of medical devices, and promote the high-quality development of the medical device industry.
On June 10, Shanxi food and Drug Administration held a medical device risk research and judgment meeting in the second quarter of this year, reported the disposal of risk consultation results in the first quarter, studied and discussed the quality and safety risks of medical devices in the second quarter, and studied and discussed the State Food and Drug Administration Implementation measures of the opinions on further promoting the high-quality development of medical device standardization issued by the National Standardization Committee.
Heilongjiang
On April 13, Heilongjiang food and Drug Administration issued the notice on the investigation and treatment of potential risks in the quality and safety of medical devices in the province, focusing on the investigation and treatment of epidemic prevention and control medical devices, centralized procurement of selected products, sterile and implantable medical devices, etc.
From May 25 to 27, in order to strengthen the risk management of medical devices, 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 requirements of the State Food and Drug Administration for the investigation and treatment of potential risks in the quality and safety of medical devices and strengthening the inspection of disposable sterile syringes, The medical device Department of Heilongjiang food and Drug Administration conducted a comprehensive risk investigation on Heilongjiang Shenghua medical device Co., Ltd., a large infusion enterprise in Heilongjiang Province.
Ningxia
On April 13, in accordance with the deployment requirements of the State Food and Drug Administration and in combination with local conditions, the food and Drug Administration of Ningxia Hui Autonomous Region issued the notice on conscientiously doing a good job in the supervision and inspection of the operation and use of medical devices and the investigation and treatment of potential quality and safety risks in the region in 2021, making every effort to promote the investigation and treatment of potential risks.
On May 31, after in-depth investigation, the food and Drug Administration of Ningxia Hui Autonomous Region formulated the risk consultation mechanism for medical devices in Ningxia Hui Autonomous Region (Trial), so as to further improve the accuracy of supervision and effectively improve the quality and safety assurance level of medical devices in the region.
Anhui
On April 15, Anhui food and Drug Administration organized and held the quality and safety risk analysis and judgment meeting of medical devices in the first quarter of 2021. The meeting pointed out that in accordance with the requirements of the notice of Anhui drug administration on carrying out the investigation and treatment of potential risks in the quality and safety of medical devices, we should strengthen the investigation and treatment of potential risks, effectively prevent and resolve risks, and improve the quality and safety assurance level of medical devices.
On May 26, Anhui food and Drug Administration organized a meeting to promote the investigation and treatment of potential risks in the quality and safety of medical devices.
Tibet
On April 15, the food and Drug Administration of the Tibet Autonomous Region issued the notice on the investigation and treatment of potential risks of medical devices in the region, which is scheduled to carry out the investigation and treatment of potential risks of medical devices in the region from April to October.
On May 12, the food and Drug Administration of Tibet Autonomous Region released the results of the investigation and treatment of potential risks of medical devices in Tibet Autonomous Region in the first quarter. A total of 1 medical device production unit, 352 business units, 387 users and 2 online sales units were investigated and eliminated, including the operation of medical devices with incomplete licenses, the use of unqualified medical devices 54 potential risks such as unauthorized change of business premises and warehouses.
Guangdong
On April 16, Guangdong Provincial Food and Drug Administration issued the notice on the investigation and treatment of potential risks in the quality and safety of medical devices, requiring to strengthen the risk management in the production, operation and use of medical devices and further improve the level of quality and safety assurance.
Fujian
On April 21, Fujian food and Drug Administration issued the work plan for investigation and treatment of potential quality and safety risks of medical devices in 2021.
Beijing
On April 22, Beijing food and Drug Administration organized and held the city''s key work of drug and medical device supervision and the investigation and deployment meeting of hidden dangers of drug and medical device quality and safety, strengthened risk management, improved the quality and safety assurance level of drug and medical devices in Beijing, and promoted the high-quality development of the pharmaceutical industry.
Jiangsu
On April 23, Jiangsu food and Drug Administration launched the investigation and treatment of potential quality and safety hazards in the production, operation and use of medical devices, and urged enterprises to implement the main responsibility of quality and safety and improve the level of quality management through comprehensive investigation of potential risks.
On June 23, Jiangsu food and Drug Administration organized 64 inspectors to conduct cross flight inspection on 34 medical device manufacturers in Jiangsu Province, and held a briefing meeting for inspection team leaders according to the inspection results for special risk consultation.
Qinghai
On April 23, Qinghai food and Drug Administration issued the notice on carrying out the investigation and treatment of potential quality and safety risks of medical devices, which made arrangements and requirements for strengthening the safety supervision of medical devices in Qinghai Province, and strive to achieve the work objectives of comprehensive investigation of potential risks, full implementation of governance responsibilities, comprehensive improvement of management level and comprehensive strengthening of quality assurance.
On June 25, according to the work arrangement and relevant requirements of the Party group of Qinghai food and Drug Administration on the supervision and safety production of "two products and one instrument", the medical device supervision department of Qinghai food and drug administration formed an inspection team to conduct on-site safety inspection on the medical device production enterprises in the province by combining enterprise self inspection and on-site inspection.
As of June 22, the inspection team had conducted on-site inspection on 10 enterprises and self inspection on 13 enterprises, realizing full coverage of safety inspection.
Jiangxi
On April 25, Jiangxi food and Drug Administration issued the notice on printing and distributing the work plan for the investigation and treatment of potential quality and safety risks of medical devices in Jiangxi Province, requiring the large-scale investigation and treatment of potential quality and safety risks of medical devices.
On May 20, Jiangxi food and Drug Administration issued the notice on holding the training course on the publicity and implementation of Jiangxi Medical Device Supervision and administration regulations and the promotion meeting on the investigation and treatment of hidden dangers of medical device quality and safety.
On May 28, Jiangxi food and Drug Administration organized and held a promotion meeting on the investigation and treatment of potential risks in the quality and safety of medical devices in Jiujiang. At the meeting, the Jiangxi provincial food and Drug Administration announced the supervision work of the COVID-19 test reagent, the risk detection and treatment, and the supervision of medical device network sales, and focused on the risk points and the problems encountered during the investigation. And re deploy the investigation and treatment of potential risks in the quality and safety of medical devices in the next step.
Inner Mongolia
On April 26, the food and Drug Administration of Inner Mongolia Autonomous Region organized a regional risk consultation meeting on medical device supervision in the first quarter of 2021 to report the risk monitoring, analyze and judge the severity and possible hazards, and study and formulate disposal measures.
Shandong
On April 26, Shandong food and Drug Administration issued a notice to focus on the investigation and rectification of violations in the operation of medical devices in the whole province, and promote the investigation and treatment of potential risks in the operation link.
From May 27th to June 4th, the official account of the Shandong Drug Administration issued the WeChat public issue to carry out the investigation and regulation of illegal operation of medical devices in all parts of the province.
Henan
On April 26, Henan food and Drug Administration issued the work plan for the investigation and treatment of potential risks in the quality and safety of medical devices, which made arrangements and requirements for strengthening the risk supervision of medical devices.
Guangxi
On April 26, the food and Drug Administration of Guangxi Zhuang Autonomous Region held a meeting of the chamber of Commerce on post marketing regulatory risks of medical devices in the second quarter of 2021 in Nanning. The meeting sorted out the hidden dangers of medical device quality risks found in the investigation and supervision in the first quarter, analyzed and judged the causes of medical device regulatory risks, and focused on studying effective methods to prevent and control different types of risks, Deploy the next risk prevention work.
Hubei
In April 27th, the Hubei provincial drug administration announced the plan for the investigation and management of the risks of medical devices in Hubei province. It requires that drug regulatory departments at all levels in the province carry out investigation and management by cross examination, joint inspection, entrusted inspection, tracking inspection, third party assessment, Internet plus regulation, and carry out "looking back" on key enterprises. At the same time, we should seriously investigate and deal with violations of laws and regulations, and strengthen typical demonstration and guidance.
Gansu
On April 28, Gansu food and Drug Administration organized some municipal and state market supervision departments to hold the first quarter medical device quality and safety risk consultation meeting. At the meeting, the person in charge of medical device supervision of Lanzhou, Wuwei, Baiyin, Lanzhou New Area and other municipal and state market supervision bureaus arranged and deployed around the investigation and treatment of potential quality and safety risks of medical devices, promoted the comprehensive self-examination of enterprises, and put forward specific and feasible opinions and suggestions on how to carry out the investigation of potential quality and safety risks of medical devices.
Shaanxi
On April 30, Shaanxi food and Drug Administration issued a notice to comprehensively deploy the investigation and treatment of potential risks of medical devices, strengthen the risk management of medical devices, improve the level of quality and safety assurance, and ensure the safety of public 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, including supervision and inspection, quality supervision and sampling, adverse event monitoring, online transaction monitoring, complaint reporting, public opinion monitoring, investigation and handling of illegal cases and product recall, studied and discussed the implementation of risk prevention and control measures determined at the risk consultation meeting in the first quarter, and deeply analyzed the current safety risk situation of medical device supervision, Comprehensively study and judge the risk changes and new risk information, and propose to speed up the construction of the "integrated" pattern of the comprehensive risk management system of provinces, cities and counties, so as to improve the risk management ability.
Xinjiang
On May 10, the food and Drug Administration of Xinjiang Uygur Autonomous Region held a symposium on medical device quality and safety risk investigation on the basis of four regional training courses on medical device laws and regulations held in Urumqi and Turpan.
Jilin
On May 13, Jilin food and drug administration carried out risk consultation on medical devices in the first quarter and rectified risk clues one by one in order to eliminate potential risks.
On May 14, Jilin food and Drug Administration organized and held the provincial medical device risk association business federation meeting.
On May 18, Jilin food and Drug Administration issued a notice to comprehensively carry out the supervision and management of the operation and use of medical devices and the investigation and treatment of potential quality and safety risks, further improve the quality and safety assurance level and promote the high-quality development of medical device industry in Jilin Province.
Zhejiang
On May 13, according to the relevant requirements of the State Food and Drug Administration on the investigation and treatment of potential risks in the quality and safety of medical devices, Zhejiang food and drug administration made precise deployment, made solid progress, and made every effort to improve the efficiency of risk management of medical devices in Zhejiang Province.
Chongqing
On May 18, Chongqing food and Drug Administration issued a notice to comprehensively promote the investigation and treatment of potential risks in the quality and safety of medical devices in the whole city. The notice made it clear that to carry out the investigation and treatment of potential risks, we should strengthen the risk management of medical devices, further improve the level of quality and safety assurance, effectively prevent and resolve safety risks, and promote the high-quality development of the medical device industry.
Yunnan
On May 31, Yunnan food and Drug Administration issued a notice to deploy the investigation and treatment of potential risks in the quality and safety of medical devices.
Shanghai
From June 7 to 11, Shanghai food and Drug Administration organized the 2021 medical device inspector training and special flight inspection mobilization meeting for risk investigation and treatment. The meeting stressed the need to conscientiously implement the work requirements of the municipal government and the requirements of the notice on risk investigation and governance of the State Food and drug administration, earnestly do a good job in the three key tasks of investigation and governance of potential risks of medical devices, risk consultation and standardization, firmly hold the bottom line of product safety and ensure the safety of people''s use of machinery.
Sichuan
Sichuan food and Drug Administration organized and held the risk consultation meeting on quality and safety supervision of medical devices in the first quarter. The meeting summarized the investigation and treatment of potential risks of medical devices in the first quarter, and analyzed and evaluated the risk points of 142 production links.
Tianjin
Tianjin Food and Drug Administration organized and held a risk consultation meeting on medical device production supervision in the second quarter of 2021. The meeting identified the control of the "flame resistance" index of medical protective clothing products as the main risk point, and listened to the control methods and expected effects adopted by the representatives of various manufacturers on the "flame resistance" index. In combination with the situation that the enterprise did not conduct in-depth research and control on the "flame resistance" index, the meeting gave risk prevention and control suggestions, that is, implement hierarchical management on products, distinguish specifications and models according to product use scenarios, and make it clear in the label of the manual.
Liaoning
Liaoning food and Drug Administration strengthened the investigation and inspection of production and operation enterprises and users in combination with the implementation of the regulations on the supervision and administration of medical devices.
Up to now, all municipal bureaus and inspection offices have investigated 104 manufacturers of sterile implant medical devices, identified 112 potential risks and eliminated 106 potential risks; 2983 operating enterprises were investigated, 19 potential risks were found, 19 potential risks were eliminated, 9 cases were filed, 13 were warned and 26 were ordered to rectify; 2468 users were investigated, 27 potential risks were found, 27 potential risks were eliminated, 10 were warned and 25 were ordered to rectify.
Hebei
Hebei food and drug administration actively carried out the investigation and treatment of potential risks in the quality and safety of medical devices, focusing on nine aspects: epidemic prevention and control medical devices, centralized procurement of selected products, sterile and implantable medical devices, and online sales of medical devices. Since May, 984 potential risks have been identified, 959 have been eliminated and 11 long-term mechanisms have been established.
Guizhou
In order to further strengthen the quality supervision of medical device products in Guizhou Province and effectively maintain the market order, in accordance with the requirements of the notice on the investigation and treatment of potential risks of medical device quality and safety in Guizhou Province, Guizhou food and drug administration has carried out flight inspection on some medical device operating enterprises and users.
Hunan
In combination with the key points of the province''s medical device supervision and the "two products and one device" supervision and inspection plan, Hunan food and Drug Administration formulated the work plan for investigation and treatment of potential risks of medical device quality and safety in Hunan Province in 2021, defined the work objectives, principles, arrangements and requirements, determined the key points of investigation and treatment, and comprehensively combed and investigated potential risks.
In May this year, Hunan food and Drug Administration organized the first quarter medical device quality and safety risk conference chamber of Commerce to study and discuss the quality and safety risk of medical devices in the province. According to the risk consultation opinions, it sent letters to 13 medical device manufacturers with the top 10 adverse event reports and high risk, urging them to take effective measures to prevent and control