2021 Medical Device Registration Work Report of the National Medical Products Administration

2021 Medical Device Registration Work Report of the National Medical Products Administration
Source: National Medical Products Administration website
Accelerate the construction of a medical device registration management system that is compatible with high-quality development, and promote industrial innovation and development.
1、 Medical device registration work situation
（1） Fully guarantee the overall situation of epidemic prevention and control
We will continue to do a good job in emergency approval for the prevention and control of COVID-19. In 2021, the National Bureau approved 14 COVID-19 detection reagents. By the end of 2021, 68 COVID-19 detection reagents (including 34 nucleic acid detection reagents, 31 antibody detection reagents, and 3 antigen detection reagents) have been approved, with a production capacity of 51.306 million people/day, providing a strong guarantee for the normalization of epidemic prevention and control. Initiate the monitoring of COVID-19 mutants and the evaluation of reagent detection ability to ensure the quality of approved reagents for COVID-19 mutants.
In addition, the National Medical Products Administration has approved 16 instruments and equipment, including gene sequencers, nucleic acid detectors, ventilators, and blood purification devices. By the end of 2021, 108 medical devices for COVID-19 prevention and control have been approved.
Five national standards, including Quality Evaluation Requirements for novel coronavirus Nucleic Acid Test Kits, were approved and released, and the project establishment and drafting of the international standard Medical Electrical Equipment Part 2-90 Basic Safety and Basic Performance of High Flow Respiratory Therapy Equipment were completed. The standard was officially released on the websites of the International Electrotechnical Commission (IEC) and the International Organization for Standardization (ISO) on August 30, 2021, This is the first international standard for medical devices for the prevention and control of COVID-19 proposed and completed by China.
（2） Building a New Framework for Medical Device Registration Management Regulations
Two regulations, namely the Measures for the Administration of Registration and Filing of Medical Devices (Order No. 47 of the State Administration of Market Regulation) and the Measures for the Administration of Registration and Filing of In Vitro Diagnostic Reagents (Order No. 48 of the State Administration of Market Regulation), have been issued. Announcement No. 76 of 2021 on the Implementation of the Measures for the Administration of Registration and Filing of Medical Devices and the Measures for the Administration of Registration and Filing of In Vitro Diagnostic Reagents, clarifying the requirements for the registration of transitional medical devices.
Announcement No. 121 of 2021 and Announcement No. 122 of 2021 on the Requirements and Format of Approval Documents for Medical Device Registration Application were issued to guide registration applicants in preparing registration application materials.
Release 9 guiding principles for clinical trials and evaluations of medical devices and in vitro diagnostic reagents, including: Notice on Issuing Technical Guidelines for Clinical Evaluation of In vitro Diagnostic Reagents Exempted from Clinical Trials (No. 74 of 2021), Notice on Issuing Technical Guidelines for Clinical Trials of In vitro Diagnostic Reagents (No. 72 of 2021) Notice on Issuing Five Technical Guiding Principles for Clinical Evaluation of Medical Devices (No. 73 of 2021) (Including five guiding principles: technical guidelines for clinical evaluation of medical devices, technical guidelines for deciding whether to conduct clinical trials of medical devices, technical guidelines for same-sex argumentation of clinical evaluation of medical devices, technical guidelines for clinical evaluation reports of medical device registration applications, and technical guidelines for product comparison explanations included in the list of medical devices exempt from clinical evaluation) Notice on Two Guiding Principles for Registration Review, including the Requirements for Submitting Clinical Trial Data of Medical Devices (No. 91 of 2021), scientifically setting clinical evaluation requirements for medical devices. Announcement No. 70 of 2021 and No. 71 of 2021 regarding the publication of the Catalogue of In Vitro Diagnostic Reagents Exempted from Clinical Trials and Clinical Evaluations have been issued, exempting 423 In Vitro Diagnostic Reagents and 1010 Medical Devices from Clinical Trials and Clinical Evaluations.
Two operating standards have been issued, including the “Operating Standards for Registration and Approval of Domestic Class III and Imported Medical Devices” (National Medical Products Administration [2021] No. 53) and the “Operating Standards for Registration and Approval of Domestic Class II Medical Devices” (National Medical Products Administration [2021] No. 54), to standardize the registration and approval work of drug regulatory departments at all levels.
Announcement No. 126 of 2021 on the Management Regulations for Self inspection of Medical Device Registration clarifies the management requirements for self inspection of medical device registration.
The Emergency Approval Procedure for Medical Devices was issued to summarize the experience in the prevention and control of the COVID-19 and improve the emergency approval requirements for medical devices.
Release the “Classification Rules for in vitro Diagnostic Reagents” (No. 129 of 2021) to guide the classification of in vitro diagnostic reagents.
A new registration management regulatory system has been established.
（3） Encourage high-quality development of the medical device industry
We will continue to encourage innovative development of medical devices and approve the launch of 35 innovative medical devices, including coronary blood flow reserve score calculation software. By the end of 2021, 134 innovative medical devices have been approved for launch, meeting the needs of the people to use high-level medical devices.
According to the priority medical device approval process, 19 medical devices, including genetic testing kits for hereditary deafness, have been approved for sale. By the end of 2021, 49 priority medical devices have been approved for sale, better meeting clinical usage needs.
Establish a biomaterials innovation cooperation platform, cooperate with the Ministry of Industry and Information Technology to launch the task of unveiling and commanding the innovation of artificial intelligence medical devices, establish a main document registration system, accelerate the launch of new materials, new technologies, and new products, and assist in the high-quality innovation and development of the industry.
Continue to support the construction of key areas such as the Boao Lecheng International Medical Tourism Pilot Zone and the Guangdong Hong Kong Macao Greater Bay Area in Hainan, guide the import of a small amount of medical devices urgently needed in clinical practice, steadily promote the pilot work of clinical real-world data application, and approve the launch of the second “femtosecond laser ophthalmic treatment system” using clinical real-world data.
Optimize the requirements for listing certification of pharmaceutical and mechanical combination products, and issue the Notice on Registration Matters of Pharmaceutical and Mechanical Combination Products (No. 52 of 2021) to accelerate the pace of listing of clinically valuable pharmaceutical and mechanical combination products.
（4） Consolidate the foundation of medical device registration management
1. The standard system continues to improve. The United Nations Standards Committee has issued the Opinion on Further Promoting the High Quality Development of Medical Device Standardization Work. Organize the 2021 World Standards Day medical device standardization theme event to strengthen the promotion of medical device standardization concepts.
Establish two standardized technical centralized units for clinical evaluation of medical devices and high-throughput sequencing for medical use, and further improve the standard organizational system; Continuously implementing the standard improvement plan, 79 industry standard revision plan projects were approved in 2021, and 146 industry standards were reviewed and released; A comprehensive optimization evaluation has been conducted on 396 mandatory standards and 62 mandatory standards under research projects. As of the end of 2021, there are a total of 1849 effective medical device standards, including 235 national standards and 1614 industry standards. The coverage and systematicity of the standard system are constantly improving.
2. Classification and naming work is more effective. Release the Work Procedure for Dynamic Adjustment of Classification Catalogues, standardize the adjustment of classification directories, and complete 1993 classification definitions; Release the revised Catalogue of Class I Medical Device Products; Develop classification rules for in vitro diagnostic reagents to standardize the management of in vitro diagnostic reagent classification; Develop principles for classifying and defining recombinant collagen and artificial intelligence products; Actively promote research on the attributes and classification of hot products, edge products, and pharmaceutical device combination products with high social attention, such as medical beauty products; Release 9 naming guidelines to further guide the standardized naming of medical devices.
3. The work of unique identification is steadily advancing. Collaborate with the Health Commission and the Medical Insurance Bureau to promote the implementation of the first batch of unique identification for high-risk varieties; Joint issuance of the second batch of implementation announcements, clarifying the implementation varieties and policy requirements; Actively promote the construction of unique identification demonstration units; The organization has improved the unique identification database, and as of now, the database has 1.05 million pieces of data. Deepen the pilot work of provincial-level unique identification, expand the range of varieties, and explore the implementation and application of unique identification.
4. Substantial progress has been made in the construction of sub centers. The two sub centers of the Medical Device Technical Evaluation and Inspection of the National Medical Products Administration in the Yangtze River Delta and the Guangdong Hong Kong Macao Greater Bay Area have officially been put into operation. The personnel allocation and management have been continuously improved, and the core business of evaluation has been carried out in an orderly manner. A proactive service mechanism for innovative medical devices has been established, and communication and guidance for applicants have been actively carried out to promote the innovative development of the medical device industry in the Yangtze River Delta and the Greater Bay Area.
5. Standardize and unify technical review standards. We have issued 73 registration technology review guidelines for animal experimental research on medical devices, including breast X-ray machines, to unify and standardize the scale of medical device registration technology review at all levels and regions, and enhance review capabilities.
（5） Strengthen the construction of medical device registration and management capabilities
1. Continuously provide training on medical device registration regulations. The National Bureau has established a preaching team to promote the requirements of the Regulations in various forms, ensuring the accuracy and authority of the dissemination. Organize two training courses for over 1000 grassroots business backbone members. Each province (district, city) bureau will incorporate the promotion and implementation of the Regulations into its annual key work, and carry out various forms of promotion and training.
Based on the bureaus of six provinces (cities) in Beijing, Shanghai, Jiangsu, Zhejiang, Shandong, and Guangdong, establish a second type of medical device evaluation training base, and carry out training according to professional expertise. Nearly 7000 people participated in 10 training sessions, laying a foundation for improving provincial evaluation capabilities.
The National Medical Products Administration’s Equipment Review Center continuously expands the content and forms of business training, organizing 10 sessions of business training for regulatory and technical personnel within the system, covering more than 9000 grassroots personnel; The “Qishen Cloud Classroom” has been launched on the Learning Strong Country platform, providing content such as regulatory interpretation and explanation of evaluation points. It includes 145 courses and has been played more than 1.1 million times in total.
2. Initiate research on regulatory systems. The National Medical Products Administration has established a regulatory and regulatory research group led by 12 provincial (city) bureaus, with the participation of each provincial (district, city) bureau. Focusing on 12 regulatory themes, focusing on tracking the progress of international regulations, closely integrating with China’s regulatory practices, problem oriented research, and providing support for the subsequent improvement of regulatory systems.
3. Continuously promote regulatory scientific research. Strengthen the construction and management of regulatory scientific research bases, complete the first batch of four key regulatory scientific research projects, and develop 37 new tools, methods, standards, and related reports. The second batch of 6 scientific key projects for medical device supervision will be selected and determined by the organization.
4. Deepen international exchanges and cooperation. Deeply participate in the research of six project teams at the International Medical Device Regulatory Forum (IMDRF), and the results document of the “Postmarket Clinical Follow up Study” led by China has been approved for release. Actively participate in the Global Medical Device Regulation Coordination Conference (GHWP), lead the development of GHWP UDI guidelines, and conduct UDI capacity building training. Organize the 12th China International Conference on Medical Device Supervision and Management (CIMDR).
（6） Strengthen the supervision and management of medical device registration
1. Carry out the cleaning and standardization work for the filing of Class I medical devices. Focusing on medical cold compress products, we will comprehensively clean up and standardize the filing of Class I medical devices in China. During the process of cleaning up regulations, the filing departments at the municipal level in each district conducted self inspections, the provincial bureau conducted inspections, and the national bureau dispatched 6 inspection teams to 11 provinces for spot checks. Subsequently, through publicity and training, supervision and notification, and year-end assessment, we will continue to increase our efforts to ensure that the cleaning and standardization have achieved good results, effectively purifying the market environment.
2. Strengthen clinical trial management. Strengthen the supervision and management of clinical trial institutions and clinical trial projects, and strengthen the promotion and training of clinical trial regulations. Serious investigation and punishment of illegal and irregular behaviors during clinical trials. The clinical trial of in vitro diagnostic reagent products of Guangzhou Hailite Biotechnology Co., Ltd. has been dealt with in accordance with the law due to issues such as the inability to trace clinical trial data discovered during the inspection.
3. Deploy and carry out the cleaning and standardization work for Class II medical devices. We will carry out nationwide standardization work for the registration and clearance of Class II medical devices, issue work plans, and further standardize the management of Class II medical device registration nationwide.
2、 Acceptance status of medical device registration application
In 2021, the National Medical Products Administration received a total of 12255 applications for initial registration, renewal registration, and change registration of medical devices in accordance with its responsibilities, an increase of 15.8% compared to 2020.
（1） Overall situation
We have accepted 5338 registration applications for Class III medical devices in China and 6917 registration applications for imported medical devices.
According to the registered varieties, there are 8540 applications for medical device registration and 3715 applications for in vitro diagnostic reagent registration.
According to the registration form, there are 2750 initial registration applications, accounting for 22.4% of all medical device registration applications; 5875 applications for continued registration, accounting for 48% of all medical device registration applications; There are 3630 applications for change of registration, accounting for 29.6% of all medical device registration applications. The proportion of registration forms is shown in Figure 1.
Figure 1 Registration Acceptance Project Registration Form Scale
（2） Sub item situation
1. Acceptance of registration of Class III medical devices within the country
There are a total of 5338 registrations for Class III medical devices in China, an increase of 26.5% compared to 2020. Among them, there are 3733 applications for medical device registration and 1605 applications for in vitro diagnostic reagent registration.
From the perspective of registration form, there are 1880 initial registrations, accounting for 35.2% of all domestic applications for Class III medical device registration; Continuation of registration for 2156 items, accounting for 40.4% of all domestic applications for Class III medical device registration; 1302 registration changes were made, accounting for 24.4% of all domestic applications for Class III medical device registration. The distribution of registration forms is shown in Figure 2.
Figure 2 Distribution of Registration Forms for Class III Medical Device Registration Acceptance Projects in China
2. Acceptance of registration for imported Class II medical devices
There were a total of 3689 registered applications for imported Class II medical devices, an increase of 11.4% compared to 2020. Among them, there are 2048 applications for medical device registration and 1641 applications for in vitro diagnostic reagent registration.
From the perspective of registration form, 435 items were registered for the first time, accounting for 11.8% of all registration applications for imported Class II medical devices; 2122 registrations have been extended, accounting for 57.5% of all applications for registration of imported Class II medical devices; 1132 registration changes were made, accounting for 30.7% of the total number of registration applications for imported Class II medical devices. The distribution of registration forms is shown in Figure 3.
Figure 3 Distribution of Registration Forms for Registration Acceptance Projects of Imported Class II Medical Devices
3. Registration and acceptance of imported Class III medical devices
There are a total of 3228 registration applications for imported Class III medical devices, an increase of 5.9% compared to 2020. Among them, there were 2759 applications for medical device registration and 469 applications for in vitro diagnostic reagent registration.
From the registration form, there are 435 items registered for the first time