To ensure safety and keep to the bottom line, promote development to catch up with the high line, take the in-depth special rectification action of medical device safety as the starting point, strictly prevent and control safety risks, serve to ensure the overall situation of epidemic prevention and control, support the high-quality development of the medical device industry, effectively ensure the safety and effectiveness of people's equipment, and welcome the victory of the 20th CPC National Congress with excellent achievements.
1、 Support the high-quality development of the industry and continue to deepen the reform of the review and approval system
1. Seriously carry out the cleaning and standardization of Class II medical devices. According to the unified deployment of the National Bureau, we seriously carried out the clearing and standardization of Class II medical devices, promoted the implementation of the main responsibility of the review and approval, focused on the non medical devices as medical devices, high class and low batch, the registration application materials and forms of medical devices that do not meet the statutory requirements, illegal addition, etc., and focused on the combination bags, collagen paste dressings, chitosan containing dressings, medical software, physical therapy devices, etc, Implement full coverage cleaning. All relevant units shall cooperate closely and perform their own duties. All relevant rectification work shall be completed before August. All localities should also carefully understand the requirements of this cleaning and standardization work, timely communicate and publicize to the medical device registrants within their jurisdictions, and assist in doing a good job of this cleaning and standardization work.
2. Fully implement the medical device registrar system. In combination with the actual development of the medical device industry in our province, we will further strengthen the communication and exchange with the National Bureau and other provincial and municipal drug regulatory departments, strengthen regional coordination, actively explore the implementation mechanism combining territorial supervision and joint supervision, cooperate in the verification of the quality management system for entrusted production registration, and promote the medical device registrant to implement the main responsibility for the whole life cycle of the product. Further standardize the implementation of the registrar system, make overall use of the resources of all parties, and the inspection, testing, evaluation and certification, municipal bureaus and other units and departments need to constantly optimize their own work measures to form joint efforts and improve work efficiency.
3. Continue to deepen the construction of review and approval capacity. Take the opportunity of actively integrating into the construction of drug supervision integration in the Yangtze River Delta, strengthen communication and exchange with sister provinces and cities in the Yangtze River Delta, strengthen the business training of approval reviewers, increase the recruitment and introduction of high-quality professionals, and cultivate a strong team of professional reviewers. We will continue to improve and revise the review procedures and management systems, strengthen cooperation with medical device industry associations, colleges and universities, scientific research institutes, etc., form effective mechanisms such as joint meetings and expert consultation, and improve the level of scientific review and approval. Further optimize the work process, shorten the time limit for approval, learn from developed provinces, and set a good example for the reform of "decentralization, management and service". According to the situation and tasks of epidemic prevention and control, continue to do a good job in the review and approval of medical devices for epidemic prevention and control.
4. Strengthen the service for industrial development. We will continue to do a good job in the review and priority approval of innovative medical devices, and focus on helping to fill gaps in the province and provide products with high technology content. In conjunction with inspection and testing, administrative acceptance, certification and evaluation departments, we will organize expert special classes, increase communication with local governments, go deep into local government departments and industrial parks, high-tech production enterprises, Class III medical device manufacturers, professional research and development institutions, and enterprises related to thermal moxibustion products to provide assistance and guidance, and help local governments to introduce high-quality projects that meet the actual needs, Efforts should be made to solve the bottleneck problems in the industrial development and promote the transformation and upgrading of the medical device industry in our province. All localities should timely grasp the industrial development trends within their jurisdictions, communicate with the provincial bureau in a timely manner, and jointly promote the business environment and high-quality industrial development.
2、 Focus on quality and safety risks and carry out in-depth special rectification
5. Deeply carry out special rectification of medical device safety. The regulatory departments at all levels, in accordance with the requirements of the special rectification action plan for drug safety of the National Bureau, and in combination with their respective responsibilities, formulate a special rectification implementation plan, and further carry out the special rectification of medical device safety. Production link: severely crack down on production without certificates, registration and filing fraud, fabrication of production records, inspection records, etc. Operation and use link: severely crack down on unlicensed operation of medical devices, operation and use of medical devices that have not been registered or filed, illegal sales of medical devices on the Internet, illegal purchase and sales of medical devices through forging qualification documents, leasing and lending licenses, etc. We will strictly investigate, prevent and control quality and safety risks, investigate and deal with a number of major cases, publish a number of typical cases, transfer a number of criminal clues, eliminate a number of potential risks, improve the regulatory mechanism, plug regulatory loopholes, eliminate regulatory blind spots, and improve regulatory capacity.
The regulatory authorities at all levels should maintain a high pressure to crack down on violations of laws and regulations, and promptly pursue the products involved in the investigation and handling of cases involving high-risk medical devices; It is necessary to strengthen the notification of joint investigation and handling of cases. For those suspected of committing crimes, the connection between execution and punishment should be made in a timely manner. Enterprises that have repeatedly violated laws and regulations and serious violations of laws and regulations shall be severely punished in accordance with the law. Timely notify the discipline inspection and supervision department of the clues of suspected violations. For typical cases investigated and dealt with, public information will be made public after public opinion evaluation and judgment. The provincial bureau will select typical cases and report them, forming a powerful deterrent effect.
6. Comprehensively renovate the first class medical device products of the application category. All municipal bureaus shall, in accordance with the spirit of the Notice on the Implementation of Category I Medical Device Product Catalog and other documents, continue to clean up and standardize the medical cold compress and other registered products adjusted by the new catalog, actively carry out self inspection, and timely correct any problems found. Focusing on the first class medical devices such as adhesive, liquid (paste) dressings and drug dispensers, in combination with the Supplementary Inspection Methods for Identification and Content Determination of 17 Kinds of Chemical Drugs in Adhesive Medical Devices issued by the National Bureau, we carried out daily supervision and sampling inspection of key products, and continued to crack down on fraudulent related products. Strictly investigate the illegal behaviors such as organizing production without filing, not complying with the approved product technical requirements, production in the unapproved site, nonstandard product specifications and labels, false publicity, and illegal addition, and prevent the occurrence of regional systematic risks.
7. Carry out in-depth investigation and rectification of potential risks. Focusing on epidemic prevention and control, national centralized procurement and selection, sterile and implantable, innovative medical devices and other key products, focusing on new registrants, new enterprises (workshops, production lines), cross provincial and multi-point entrustments of registrants, as well as enterprises with many problems found in previous supervision and inspection, spot check, monitoring, complaint reporting and other aspects, focusing on online sales and third-party transaction services, we carried out in-depth risk troubleshooting and governance. The provincial bureau will organize the formulation of a special work plan, and the municipal bureaus should strictly implement the plan to ensure effective results.
The regulatory authorities at all levels should focus on risks, enterprises, products and disposal, and conduct regular risk consultations. For the problems and risks of supervision and inspection, spot check monitoring, public opinion reflection, complaints and reports, establish a list of problems, implement the cancellation management, and report quarterly.
8. Deeply carry out the governance of "online clearing and offline standardization" of medical devices. Adhere to the principle of "network management network", make full use of the provincial drug network transaction supervision system, strengthen data analysis, study and judge the development trend and risk points of medical device network sales, focus on medical devices such as sticking, liquid (paste) dressing, and drug dispensers with high social concern and more public opinions, and focus on registrants who have frequent violations of laws and regulations, and operators who engage in illegal online sales, We will adopt various methods to carry out online and offline standardized governance, strengthen cooperation with public security organs and market supervision departments, and severely crack down on illegal online sales of medical devices. The provincial bureau strengthened the inspection on the performance of platform enterprises and the monitoring of online sales, supervised and inspected at least once a year, urged continuous compliance, and promptly transferred relevant clues.
The regulatory departments at all levels shall implement the daily supervision on the online sales enterprises of medical devices, and supervise and inspect the online sales enterprises at least once every two years. Immediately investigate and deal with the clues of violations found and transferred through inspection; If false publicity is involved, it shall be transferred to the advertising supervision department for investigation and punishment; If the violators cannot be verified, the relevant departments shall be notified to be included in the abnormal operation directory, and the platform enterprises shall be instructed to stop serving the illegal enterprises according to law.
9. Deeply carry out supervision and inspection. On the basis of the medical device business license (filing) and special rectification of fraudulent products carried out in 2021, we will strengthen supervision, inspection and cross inspection, and focus on the regions where Class I medical device production is concentrated, where medical device business enterprises are concentrated, where there are a large number of medical device third-party logistics enterprises, and where medical institutions have many public opinion problems. Urge all localities to effectively implement their regulatory responsibilities, standardize the filing of Class I medical device products and the licensing (filing) of medical device business, and strengthen the daily supervision of medical device business (including online sales), use links, and Class I medical device manufacturers.
3、 Focusing on medical devices for epidemic prevention and control, comprehensively strengthen daily supervision
10. Strengthen the production supervision of epidemic prevention products. The provincial bureau shall carry out at least one inspection of the whole project of the quality management system for medical protective clothing, medical masks, forehead temperature guns and other manufacturers throughout the year, and handle the existing problems in a timely manner. For enterprises that have found many problems in cross-border production transfer, supervision and inspection, and spot check since the epidemic, and have complaints and reports, the supervision and inspection should be strengthened. Those that do not meet the requirements of production quality management norms should be rectified within a time limit, and those with serious defects should be ordered to stop production immediately. Flight inspection mode is adopted for relevant inspections. The provincial bureau formulates the annual supervision and inspection plan for Class II and Class III medical device manufacturers. The whole project of sterile and implantable medical device manufacturers shall be inspected at least once a year, and other enterprises shall be fully covered within two years. If any violation of laws and regulations is found, it shall be investigated and dealt with according to law, and the production of medical devices shall be effectively standardized.
11. Strengthen the supervision of the operation and use of medical devices. All municipal bureaus shall carry out administrative licensing (filing) work in strict accordance with laws and regulations, carefully verify the application conditions of enterprises, strictly check the false licensing (filing) materials, properly control the "access" of enterprises, and put an end to lowering the access conditions and handling the licensing filing without legally verifying the conditions. Strengthen the supervision after the business license (filing) of medical devices, especially the operating enterprises undertaking the reserve of epidemic prevention materials, focus on the storage of COVID-19 testing reagents and cold chain transportation management, and strengthen the inspection of epidemic prevention and control medical devices related products sold online. Strictly investigate the acts of providing false information or taking other deceptive means to obtain the license filing certificate, forging, altering, buying, selling, leasing, lending the license filing certificate, operating medical devices without license filing or operating medical devices without obtaining the registration certificate or filing certificate, and severely crack down on "shell companies" and "invoicing companies" that do not require certificates, purchase and sales records, products cannot be traced, and have no actual business premises. We will continue to strengthen the special rectification of medical instruments, condoms and decorative colored flat glasses that can be used for medical beauty, and strictly investigate the illegal operation of sodium hyaluronate for injection, contact lenses and other products that are widely used and highly concerned by the public.
The regulatory authorities at all levels should strengthen the supervision of medical device users, strengthen the inspection of medical beauty institutions, private hospitals, physical examination institutions, township health centers (institutes), dental clinics, focus on donated and transferred second-hand medical devices and disposable high value consumables and other products, and severely crack down on the reuse of disposable medical devices, purchase, use of smuggled, illegally renovated and assembled medical devices Use of unregistered, expired, invalid, obsolete medical devices and other illegal acts.
12. Strengthen the management of clinical trial institutions and trial projects. In accordance with the requirements of the newly revised Clinical Trial Quality Management Specification for Medical Devices to be issued soon, actively cooperate with provincial health commission and other departments to strengthen the management of clinical trial projects and the supervision and inspection of clinical trial institutions. For the acts of providing false declaration materials and taking other deceptive means to defraud the registration certificate in the registration declaration process, if one is found, it will be investigated and dealt with, and it will always maintain a high pressure on illegal acts.
4、 Strengthen inspection and monitoring to provide technical support for supervision
13. Continuously strengthen quality supervision and sampling inspection. According to the requirements of the national sampling plan, the provincial bureau did a good job in carrying out national quality supervision and sampling inspection and special sampling inspection for 18 varieties, including uric acid test kit, hollow fiber dialyzer, epidemic prevention and control medical instruments. All relevant units shall, in accordance with the requirements of the 2022 Work Plan for the Supervision and Random Inspection of Medical Devices in Jiangxi Province issued by the provincial bureau, strengthen the random inspection of medical devices for epidemic prevention and control produced by registered persons in our province through online, offline, production, operation, use and other links, so as to achieve full coverage and random inspection. If the products fail to pass the spot check, the supervision departments at all levels shall timely control the products, urge the enterprises to analyze the causes, make rectification in place, and track that the enterprises can be released to the market after passing the spot check.
14. Continuously strengthen the monitoring of adverse events. The provincial bureau continued to strengthen the adverse event monitoring system and capacity building, and improved the risk assessment and aggregation signal processing capabilities. In accordance with the deployment of the National Bureau for key monitoring work, we carried out key monitoring of adverse events of related varieties, continued to closely monitor the monitoring information of adverse events of epidemic related varieties, and carried out quality assessment on adverse event reports of medical devices in cities with districts. Carry out special inspection in combination with daily monitoring, urge the registrant to earnestly fulfill the main responsibility of monitoring, improve the adverse event monitoring system, actively collect and report adverse events, fully tap the potential of the monitoring information system, and timely and efficiently carry out risk signal evaluation and disposal.
Each municipal regulatory department shall have a special monitoring organization for adverse events of medical devices, and the county-level regulatory department shall have special personnel responsible for monitoring adverse events. Guide and urge the operating and using units of medical devices to implement their main responsibilities, carry out post marketing adverse event monitoring according to law, actively collect, track and analyze, and timely report suspicious adverse event information, and timely take risk control measures for medical devices with identified risks.
5、 Improve the regulatory capacity and go all out to strengthen infrastructure
15. Actively carry out the publicity, implementation and training of laws and regulations. Carefully plan the work ideas, study and analyze the new changes brought by the revision of laws and regulations to the registration and supervision of medical devices. For new major reform initiatives such as self inspection of medical device enterprises, new requirements for clinical evaluation, and supporting laws and regulations of medical device regulatory regulations, strictly implement them in a strict and standard manner. In combination with the requirements for revised filing materials and operating specifications issued by the National Bureau of the People's Republic of China, organize publicity and implementation training for the Category I product catalog, and guide the filing work. It is planned to hold a phase of regulation training in May, invite leaders and industry experts from the National Bureau and other sister provinces and cities to carry out business training for medical device registration, filing, supervision, inspection and other staff throughout the province, and cooperate with industry associations to implement full coverage of regulation publicity and implementation training for medical device registrants, especially enterprise legal representatives, to guide relevant units in our province to organize medical device R&D and production activities according to laws and regulations. At the same time, local municipal bureaus should organize and carry out training on relevant laws and regulations, and do a good job of publicity and implementation training for enterprise employees, especially legal representatives; Urge the training and education of personnel in key positions of the enterprise, and take practical measures to ensure the effective operation of the production quality management system.16. Fully implement electronic review and approval. The provincial bureau will continue to improve the electronic registration application and approval system. The provincial bureau acceptance center should strengthen the connection with relevant departments, do a good job in technical support, and realize the whole process of acceptance, registration verification, review, approval, etc. in accordance with the unified requirements of the national bureau, so as to improve the level of medical device government services. Actively promote the construction of electronic archives of medical devices. Actively coordinate with relevant departments to further promote the implementation of the unique identification of medical devices, and guide enterprises to carry out product coding, data upload and maintenance. Continue to do a good job in the daily maintenance of the classification and definition system, and guide medical device manufacturers and grass-roots medical device regulatory departments to do a good job in the classification and naming of products. All municipal bureaus should pay close attention to the construction of the registration information system, submit the filing information on time, strengthen the contact with the provincial bureau acceptance center, and improve the efficiency and quality of work by means of informatization.
17. Continuously strengthen the construction of inspectors and information systems. We will improve the professional and professional inspector team at the provincial level, strengthen the guidance of the inspector center in law enforcement inspection, inspection and case handling, and help them improve their law enforcement and case handling capabilities and levels as soon as possible. Strengthen the connection between the production supervision platform of the National Bureau and the intelligent supervision platform of the provincial bureau, and realize the comprehensive, accurate and timely sharing of data. The drug regulatory departments at all levels should strengthen the data connection and use of the medical device traceability system to achieve the traceability of high-risk, implantable medical devices within their jurisdictions.
18. Strengthen scientific research on supervision and promote social co governance. Give full play to the role of Jiangxi Institute of Biomedical Industry Development and the inspection and detection capability improvement project of the provincial medical device testing center, and transform the research results in a timely manner. Follow up and pay attention to the domestic and foreign medical device regulatory trends, and effectively learn from the advanced management experience at home and abroad. Guide industry associations to strengthen enterprise training and experience exchange, and improve the self-discipline ability and level of the industry.