Medical device supervision realizes six new 2021 supervision work inventory

2021 is a milestone year in the history of the party and the country, and it is also a year of comprehensive progress in China's medical device supervision
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The regulatory authorities conscientiously implemented the major decisions and deployments of the Party Central Committee and the State Council, and strictly implemented the "four strictest" requirements.
The launch of COVID-19 prevention and control products was steadily advanced, the reform of the review and approval system continued to deepen, the quality supervision throughout the life cycle was continuously strengthened, and the supervision system The pace of building and supervision capacity has been significantly accelerated, various tasks have been advanced in an orderly and vigorous manner, and the "14th Five-Year Plan" medical device supervision work has started well
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Adhere to legislation first, and new achievements have been made in the construction of the regulatory system.
The newly revised Regulations on the Supervision and Administration of Medical Devices (hereinafter referred to as the Regulations) were released and implemented
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The regulatory department insists on reform and innovation, consolidates and expands the reform achievements of the review and approval system, establishes the registrant system, improves the clinical evaluation requirements, promotes the construction of professional and professional inspector teams, strengthens the quality risk supervision of the whole life cycle, and increases the penalties for illegal acts.
Medical device supervision has entered a new stage of the rule of law
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At the same time, the national drug regulatory system actively organized the publicity and implementation of the "Regulations", and quickly formed a strong atmosphere of learning and using the "Regulations"
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The supporting rules and regulations of the "Regulations" have been gradually improved
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The "Administrative Measures for the Registration and Filing of Medical Devices" and "Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents" were revised and released, and the revision of supporting regulations such as the "Measures for the Supervision and Administration of Medical Device Production" and the "Measures for the Supervision and Administration of Medical Device Operation" was accelerated
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The State Food and Drug Administration coordinated system resources and strengths, established 12 research groups on regulations and systems, and carried out special research on key, difficult, and hot issues in regulatory practice
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Serve the overall situation of epidemic prevention and control, and make new contributions in emergency review and approval
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The State Food and Drug Administration revised and issued the "Medical Device Emergency Approval Procedures" to ensure the timely and orderly emergency approval
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As of the end of 2021, a total of 68 new coronavirus detection reagents have been approved for the market, effectively meeting the needs of the new crown pneumonia epidemic prevention and control
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Breakthroughs in the standardization of epidemic prevention and control equipment
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China's leading international standard "Medical Electrical Equipment Part 2-90: Special Requirements for Basic Safety and Basic Performance of High Flow Respiratory Therapy Equipment" was published by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) website, "Nucleic Acid Amplification".
The international standard of "Quality Specifications for the Detection of Novel Coronavirus" was approved
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Five national standards including "Quality Evaluation Requirements for Novel Coronavirus Nucleic Acid Detection Kits" were approved and released
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Organize the revision of national standards such as medical protective clothing, and support timely and powerful epidemic prevention and control standards
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The quality and safety of equipment used for epidemic prevention and control are guaranteed
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Each province has carried out the construction of new coronavirus detection reagent testing capabilities.
As of October 2021, the provincial drug administrations where the production enterprises are located have the testing capabilities
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The National Medical Products Administration implemented full coverage unannounced inspections of newly approved manufacturers of new coronavirus detection reagents, conducted regular inspections of new coronavirus detection reagent manufacturers, and carried out three rounds of full coverage sampling inspections of new coronavirus detection reagent products to ensure product quality and safety
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In 2021, the State Food and Drug Administration will conduct unannounced inspections of 46 manufacturers of epidemic prevention and control equipment, and inspect 7,885 times in various places, effectively ensuring the quality and safety of epidemic prevention and control equipment
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Deepen reform and innovation to promote high-quality development of the industry to take new steps Innovative approval to help high-quality development
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Promote the review to move forward, and increase the support for the research and development of high-end products
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During the year, 35 innovative medical devices and 19 clinically urgently needed priority products were approved for launch
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As of the end of 2021, a total of 134 innovative medical devices and 49 clinically urgently needed priority products have been approved for listing
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The State Food and Drug Administration and the Ministry of Industry and Information Technology jointly launched the artificial intelligence medical device innovation task, and jointly issued the "14th Five-Year" Medical Equipment Industry Development Plan with the Ministry of Industry and Information Technology and other departments; Review Center) and 21 units, institutions, etc.
, to establish a biomaterial innovation cooperation platform
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Smarter review is more efficient and standardized
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The first government procurement service task of the device review center was successfully completed, and the performance was excellent; continued to strengthen the construction of the quality management system, improve the requirements for filing review, optimize the intelligent allocation of projects, scientifically adjust the review qualifications and personnel, standardize the review scale, and all mechanisms are effective Operation, review quality and efficiency continue to improve
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The registrant system is fully implemented
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Systematically summarize the pilot experience of the registrant system, strengthen the top-level design of policies, further optimize the allocation of resources, and stimulate the vitality of industrial innovation
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The drug regulatory departments of Shanghai, Jiangsu, Zhejiang, and Anhui have established an integrated cross-regional regulatory collaboration mechanism in the Yangtze River Delta
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Substantial progress has been made in pilot reforms in key regions
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The State Food and Drug Administration continued to support the construction of key areas such as Hainan Boao Lecheng International Medical Tourism Pilot Zone and Guangdong-Hong Kong-Macao Greater Bay Area
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Guiding Hainan to do a good job of importing licensed medical devices in urgent need, and the use of products has increased significantly
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Steadily promote the pilot application of clinical real-world data, and actively explore the use of real-world data for product registration
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Organized the review and approval of the second batch of pilot products, and approved the launch of the second "femtosecond laser ophthalmic treatment system" using clinical real-world data
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Clinical trial management has been continuously strengthened
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The State Food and Drug Administration organized the revision of the "Quality Management Practice for Clinical Trials of Medical Devices" and publicly solicited opinions
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Guide provinces to implement their regulatory responsibilities, strengthen the management of clinical trial institutions, and continuously improve the quality of clinical trials
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Prominent risk management, new improvement in the quality and safety of medical devices, and steady progress in the record-keeping of the first-class medical devices
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Focusing on medical cold compress products, comprehensively clean up and standardize the filing of Class I medical devices
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Through the self-inspection of the municipal market supervision bureau, the inspection of the provincial food and drug administration, the random inspection of the state food and drug administration, and the year-end assessment, the efforts to clean up and standardize have been continuously increased
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Continued in-depth investigation and management of hidden dangers
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Focusing on nine categories of products, including epidemic prevention and control medical devices, selected products for centralized procurement, and online sales of medical devices, a comprehensive investigation will be carried out, and efforts will be made to eliminate regional and systemic hidden dangers
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The drug regulatory department, together with relevant departments, will carry out the rectification of medical devices that can be used for medical beauty, comprehensively sort out the complaints and report information, and investigate and deal with them one by one
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The State Food and Drug Administration organized 89 unannounced inspections and ordered 3 to suspend production for rectification
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The targeting of quality random inspections has gradually increased
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Pay close attention to problem companies and products.
The national pumping mainly focuses on high-risk products, and the provincial pumping mainly focuses on the products produced in the jurisdiction.
The national pumping and the provincial pumping divide and cooperate to complement each other
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Urge local governments to strictly investigate and deal with substandard products
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Adverse event monitoring and evaluation of strong base and synergy
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The State Food and Drug Administration continued to improve the medical device adverse event monitoring system, selected and identified 105 monitoring sentinel sites, improved risk early warning and investigation and disposal capabilities, and effectively reduced risks by revising instructions, issuing warning information, and improving product design
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Start the key monitoring work of 37 varieties
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Special inspections on adverse events were organized for 36 enterprises in 14 provinces
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Online sales monitoring and disposal continued to make efforts
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Strengthen the construction of online sales monitoring platform, and realize functions such as monitoring, researching and judging, and transferring online sales of violations of laws and regulations
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Continue to carry out the "net cleanup" campaign, and organize inspections of online sales companies and third-party platforms
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Create a new situation for social co-governance
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The State Food and Drug Administration organized the National Medical Device Safety Publicity Week activities to publicize the achievements of the party's century-old medical device, and promote innovation and high-quality development
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Strengthening infrastructure construction, consolidating the foundation of supervision and achieving new results The standard system continues to improve
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The State Food and Drug Administration and the National Standardization Administration issued the "Opinions on Further Promoting the High-Quality Development of Medical Device Standardization"; together with the Ministry of Industry and Information Technology, the Medical Equipment Industry and Application Standardization Working Group was established; approved the establishment of two focal points for clinical evaluation and medical high-throughput sequencing unit
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The State Food and Drug Administration continued to implement the standard improvement plan.
In 2021, 79 industry standard formulation and revision projects were approved, and 146 industry standards were reviewed and released
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Comprehensive evaluation of 396 mandatory standards and 62 mandatory standard projects
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As of the end of 2021, there are 1,849 valid standards, including 235 national standards and 1,614 industry standards.
The coverage and systemicity of standards have been further improved
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Classification naming works more efficiently
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The State Food and Drug Administration formulated and released the "Dynamic Adjustment Procedures for the Classification of Medical Devices", revised and released the "Class 1 Medical Device Product Catalog", issued the "Classification Rules for In Vitro Diagnostic Reagents", and formulated guidelines for the classification and definition of recombinant collagen and artificial intelligence products Based on the principle, actively promote the research on the attributes of hot products, edge products and combination products of medicine and equipment that can be used for medical and aesthetic medical devices and other high-profile products
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Steady progress has been made in the unique identification of medical devices
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The State Food and Drug Administration, together with the National Health Commission and the National Medical Security Administration, promoted the implementation of the unique identification of high-risk medical devices, jointly issued the second batch of implementation announcements, and actively promoted the selection of demonstration units
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Improve the unique identification database, as of now, the database has 1.
21 million pieces of data
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Regulatory scientific research has been carried out solidly
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Strengthen the construction of regulatory scientific research bases and key laboratories of the State Food and Drug Administration, complete the first 4 research projects of the China Drug Regulatory Science Action Plan, and formulate 35 new tools, new methods, new standards and related reports
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Select the second batch of 7 key projects
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A total of 29 key laboratories for medical devices were identified in the two batches
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Pay close attention to the improvement of capacity, achieve new breakthroughs in the construction of supervision capacity, and improve the provincial-level review and approval capacity
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The State Food and Drug Administration continued to conduct training on regulations, strengthened research and exchanges on hot, difficult, and common issues, and organized 2 training courses for more than 1,000 grass-roots business backbones
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Relying on the 6 provincial (municipal) drug administrations of Beijing, Shanghai, Jiangsu, Zhejiang, Shandong and Guangdong, a second-class medical device review training base has been established, and training has been carried out according to professional expertise.
A total of nearly 7,000 people have been trained in 10 sessions
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The Device Review Center organized 10 training sessions, covering more than 9,000 person-times; the "Device Review Cloud Classroom" was launched on the "Learning Powerful Nation" learning platform, providing interpretation of regulations and review points, including 145 courses, which were played more than 1 million times in total, and the social response Good
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The capacity of inspectors continued to increase
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The State Food and Drug Administration promotes the construction of inspection and training bases, and builds a training system that integrates research, training and drills
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Organized 2 phases of national inspector training; hired 70 national inspectors; held 9 special education sessions for in vitro diagnostic reagents, implantable medical device production control, etc.
, training 6,285 person-times, and the inspection ability and level continued to improve
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Sub-center construction has made substantial progress
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Implement the national regional development strategy, and smoothly promote the establishment of the Yangtze River Delta sub-center and the Greater Bay sub-center for the medical device technical review and inspection of the State Food and Drug Administration
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Establish a full-coverage review quality management system to achieve unified assignment of review tasks
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Build an active service mechanism for innovative products, strengthen communication with applicants, and effectively promote industrial innovation and development
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The level of informatization has been steadily improved
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The integrated construction of review and approval has been completed, and the medical device government service system of the State Food and Drug Administration has been incorporated into the online service hall, providing basic support for the full implementation of "one-stop service"
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Issue the electronic licenses of the State Food and Drug Administration.
By the end of 2021, 8,010 electronic licenses for medical devices will be issued
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The variety file system has been initially established to promote the aggregation of big data and inter-connection, and provide strong support for supervision
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International exchanges and cooperation continued to deepen
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The State Food and Drug Administration organized and participated in the International Medical Device Regulators Forum (IMDRF) meeting, and the "post-marketing clinical follow-up study" led by my country was approved and released
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Actively participated in the Global Council for Harmonization of Medical Device Regulations (GHWP), took the lead in formulating unique identification guidelines, and carried out unique identification capacity building training, which was well received
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The 12th China International Conference on Medical Device Supervision and Administration (CIMDR) was successfully held, which attracted the active participation of representatives of international regulatory authorities, relevant international organizations and Chinese and foreign enterprises, and was praised by many parties
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(reported by our reporter Man Xue)