Recently, the website of the National Medical Products Administration issued the *Annual Report on the Administration of Medical Device Standards in China (2020)*.
　　In 2020, guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, the National Medical Products Administration adhered to the people-centered development philosophy, strictly implemented the requirement of "the most rigorous standards", coordinated epidemic prevention and control and regulatory work, vigorously promoted all work on medical device standardization, and provided a strong guarantee for the high-quality development of medical devices.
　　I. Research on Epidemic Prevention and Control Standards
　　Urgent Development of Key Standards for Epidemic Prevention and Control
　　We urgently organized the formulation of YY/T 1799-2020 *Technical Requirements for Reusable Medical Protective Clothing* and released the standard text in a timely manner. We applied for the establishment of 6 national standards related to epidemic prevention and control, including special safety standards for COVID-19 nucleic acid detection reagents and high-flow respiratory therapy equipment, which are being formulated as scheduled. We urgently formulated the English versions of 6 national standards for key medical supplies for epidemic prevention and control: *Technical Requirements for Medical Protective Masks*, *Technical Requirements for Disposable Medical Protective Clothing*, *Cardiopulmonary Bypass Systems - Heat Exchange Water Tanks*, *Cardiopulmonary Bypass Systems - Roller Blood Pumps*, *Pneumatic Extracorporeal Counterpulsation Devices*, and *Disposable Intravenous Infusion Needles*.
　　Active Application for International Standard Projects on Epidemic Prevention and Control
　　On the basis of applying for national standard projects, we simultaneously applied for international standard projects related to epidemic prevention and control, including special safety standards for COVID-19 nucleic acid detection reagents and high-flow respiratory therapy equipment. Among them, the project *Medical Electrical Equipment - Part 2-90: Basic Safety and Essential Performance of High-Flow Respiratory Therapy Equipment* was adopted by the International Electrotechnical Commission (IEC) and the International Organization for Standardization (ISO) with high approval rates of 94.4% and 94.7% respectively, and a Chinese expert serves as the project leader. This is the first international standard project for medical devices related to COVID-19 epidemic prevention and control proposed and successfully established by China.
　　Full Efforts in Technical Support for Epidemic Prevention and Control Standards
　　We carried out a comparison of domestic and foreign standards for medical devices for epidemic prevention and control. We urgently organized a comparative analysis of key technical indicators of domestic and foreign standards for 26 types of key guaranteed medical devices urgently needed for epidemic resistance, such as medical protective masks, medical protective clothing, intensive care ventilators, and extracorporeal membrane oxygenators (ECMO).
　　We organized research on emergency sterilization technologies for medical protective products. We drafted *Emergency Specification for Irradiation Sterilization of Disposable Medical Protective Clothing (Temporary)* and *Emergency Reference Method for Accelerated Desorption of Medical Protective Products after Ethylene Oxide Sterilization (Temporary)*, effectively shortening the time for medical protective clothing, medical masks and other products to be put into use under emergency conditions.
　　We actively organized scientific research on COVID-19 epidemic prevention and control. We coordinated the research on the topic "Technical Research and Product Development & Evaluation of Medical Protective Clothing" in the special national emergency project for the COVID-19 epidemic.
　　II. Medical Device Standard System
　　Clarifying the Positioning of Mandatory Industrial Standards for Medical Devices
　　On July 7, 2020, the National Medical Products Administration issued the *Notice on Further Strengthening the Administration of Mandatory Industrial Standards for Medical Devices*, clarifying the legal status of mandatory industrial standards for medical devices and specific requirements for further optimizing the standard system.
　　Carrying Out Preliminary Research for the 14th Five-Year Plan
　　We organized all units to carefully study the medical device standard plan for the 14th Five-Year Plan period under the framework of the 14th Five-Year Plan for Drug Safety, combined with the actual industrial development and regulatory needs of various technical fields of medical device standards.
　　Improving Management Procedures for Key Links of Medical Device Standards
　　We formulated the *Principles for the Establishment of Medical Device Industrial Standards (Trial)* and *Working Procedures for Medical Device International Standardization*, revised the *Key Points for Medical Device Standard Review*, issued the principles and requirements for the transformation of international medical device standards, put forward new requirements for the formulation of mandatory medical device standards, and further standardized and improved the working procedures and requirements for key links of medical device standards.
　　III. Completion of the 13th Five-Year Plan Standard Formulation and Revision Tasks
　　In strict accordance with the requirements of the *Measures for the Administration of Medical Device Standards* and the *Specifications for the Administration of Medical Device Standard Formulation and Revision*, we organized and guided the medical device standardization (sub-)technical committees or technical competent authorities (hereinafter referred to as standard committees (technical competent authorities)) to complete the medical device standard formulation and revision tasks on schedule and with quality guaranteed.
　　In 2020, 27 national medical device standard formulation and revision projects and 87 industrial medical device standard formulation and revision projects were issued; 24 national medical device standards, 125 industrial medical device standards, and 10 amendment sheets to industrial medical device standards were released. As of December 31, 2020, there were a total of 1,758 medical device standards, and the medical device standard system was continuously optimized.
　　Of the 500 medical device standard formulation and revision tasks in the *13th Five-Year Plan for National Drug Safety*, 561 projects have been established, exceeding the target by 12%, and the special plan for improving the quality of medical device standards during the 13th Five-Year Plan period was successfully completed.
　　Significant Increase in the Number of Standards
　　A total of 292, 553 and 476 medical device standards were released during the 10th Five-Year Plan, 11th Five-Year Plan and 12th Five-Year Plan periods respectively. During the 13th Five-Year Plan period, 710 medical device standards have been released, an increase of 49% compared with the 12th Five-Year Plan period, among which the number of national standards released decreased by 15% and the number of industrial standards released increased by 59%. A total of 149 medical device standards were released in 2020, an increase of 93% over the previous year. The number of medical device standards released has increased significantly since the implementation of the 10th Five-Year Plan in 2001.
　　More Rational Standard Structure
　　As of December 31, 2020, according to the standard objects, among the current valid medical device standards, there are 286 basic standards, accounting for 16%; 54 management standards, accounting for 3%; 422 method standards, accounting for 24%; and 996 product standards, accounting for 57%.
　　Of the 149 standards released in 2020, 27 are basic standards, 6 are management standards, 30 are method standards, and 86 are product standards. The proportion of basic standards in the annual released standards has increased year by year, from 5% in 2018 to 18%, and the structure of the medical device standard system has become more rational.
　　More Comprehensive Coverage of Standard Fields
　　As of December 31, 2020, according to the *Chinese Standard Literature Classification Code*, the current valid medical device standards are mainly classified between Comprehensive Medical Devices (C30) and Medical Hygiene Products (C48). The top 5 categories by proportion are: Medical Laboratory Equipment (C44) 14%, General and Microsurgical Instruments (C31) 11%, Orthopedic Instruments (C35) 11%, Dental Instruments, Equipment and Materials (C33) 10%, and Medical Radiological Equipment (C43) 9%. Medical device standards basically cover all technical fields of medical devices such as medical electrical equipment, surgical instruments, and surgical implants.
　　Optimized Standard Binding Force
　　In accordance with the requirements of the *Measures for the Administration of Mandatory National Standards* and the *Notice on Further Strengthening the Administration of Mandatory Industrial Standards for Medical Devices*, we further optimized and improved the system of mandatory national standards and mandatory industrial standards for medical devices. Through coordination, 2 mandatory medical device standards in the field of medical optics were transferred from the Ministry of Industry and Information Technology to the National Medical Products Administration.
　　As of December 31, 2020, there were 397 current valid mandatory medical device standards, accounting for 23%, including 92 mandatory national standards and 305 industrial standards. Among the 397 mandatory medical device standards, 106 are basic and general standards (27%), 2 are method standards (1%), and 289 are product standards (72%). Basic and general standards mainly involve general product safety and technical requirements; 1 method standard is planned to be integrated and revised into a recommended industrial standard for medical devices after implementation evaluation in 2020. Statistics on mandatory medical device standards released from 2016 to 2020.
　　Implementation of Medical Electrical Equipment Safety Standards
　　In April 2020, the new version of GB 9706.1-2020 *Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance* was officially released and will be implemented on May 1, 2023. It is a basic and general safety standard to be followed by medical electrical equipment. This standard and its parallel and specialized standards adopt the IEC 60601 series of international standards, including 74 IEC 60601 series standards suitable for transformation. The National Medical Products Administration organized the formulation of a package of standard transformation, numbering and publicity plans to promote the transformation of the series of standards in an orderly manner. As of December 31, 2020, 15 standards have been released, 39 have completed formulation and revision and are under standard review and publisher proofreading, 15 are under formulation and revision, and 5 new specialized safety standards requiring transformation are applying for national standard establishment.
　　IV. Standard Organization Structure Construction
　　In 2020, the National Medical Products Administration approved the establishment of the Technical Competent Authority for Medical Robot Standardization, and the approved National Technical Competent Authority for Quality Management and General Requirements for Clinical Evaluation of Medical Devices is being promoted in accordance with procedures. Since the establishment of the first medical device standard committee in 1980, the number of standard committees (technical competent authorities) has increased to 33, including 13 general standard committees (TC), 13 sub-standard committees (SC) and 7 technical competent authorities.
　　V. Refined Standard Management
　　Sorting out the Current Situation of Medical Device Standards
　　We carried out exploratory research on the coverage of medical insurance catalogs and Class I medical device product standards, laying a foundation for the establishment of medical device standards. We organized the implementation evaluation of 86 mandatory medical device standards released before December 31, 2009, put forward the principles for formulating mandatory medical device standards in various technical fields, systematically sorted out the existing mandatory medical device standards, and proposed a 5-year revision plan.
　　Establishing a Long-term Mechanism for Analysis and Comparison of Domestic and Foreign Standard Differences
　　We strengthened the basic research on the comparison of domestic and foreign medical device standards, clarified that a preliminary comparative analysis report with international, foreign regional or national standards of Europe, the United States, Japan and other countries should be provided at the standard establishment stage; at the standard approval stage, the differences in important technical indicators and corresponding test methods of the standards with international and foreign standards should be compared and analyzed, and a technical difference comparison table should be provided to solidly prepare the technical reserve for the analysis of domestic and foreign medical device standard differences.
　　Strengthening Standard Publicity and Training
　　We formulated and publicly released the 2020 medical device standard publicity and training plan, organized an online training course on comprehensive knowledge of medical device standards, strengthened the publicity and interpretation of important basic and general standards, and held a free online training open course on GB 9706.1-2020 *Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance* during the National Medical Device Safety Promotion Week, with more than 5,900 participants, further unifying the understanding of the standard.
　　VI. Participation in International Standard Formulation and Revision
　　Actively Proposing New International Standard Projects
　　In 2020, we submitted 9 applications for the establishment of international medical device standards, including *Medical Infusion Sets - Part 15: Light-Resistant Infusion Sets* and *Tissue Engineered Medical Products - Quantitative Detection Method for Residual DNA in Acellular Matrix Scaffold Materials*. Among them, 1 project has been successfully established, and 2 projects have been approved by member states and entered the New Project (NP) voting stage.
　　Orderly Promoting International Standard Formulation and Revision
　　We promoted the formulation of 8 international medical device standards led or initiated by China. Among them, the first international standard project for medical devices related to COVID-19 epidemic prevention and control proposed and successfully established by China has completed the Draft International Standard (DIS) voting; 2 international standard projects, *Cardiovascular Implants - Cardiac Occluders* and *Medical Infusion Sets - Part 15: Light-Resistant Infusion Sets*, have passed the Committee Draft (CD) voting and entered the DIS voting stage; *Tissue Engineered Medical Products - Cartilage MRI Evaluation - Part 1: Clinical Evaluation Methods Using dGEMRIC and T2 Mapping Techniques* was adjusted from a Technical Report (TR) to a Technical Specification (TS), obtained unanimous approval from member states in the New Project (NP) voting stage, and entered the Working Draft (WD) discussion stage.
　　Encouraging Active Participation in International Standardization Activities
　　We organized participation in more than 20 international standardization meetings, tracked new developments of international standards in a timely manner, and participated in more than 150 international standard votes on behalf of China.
　　VII. Standard Information Disclosure
　　In 2020, 322 mandatory medical device standard texts and 808 non-adopted recommended standard texts were publicly released on the website of the Center for Medical Device Standards Management of the National Medical Products Administration (hereinafter referred to as the Standards Management Center), with a disclosure rate of 100% for both. We publicly solicited opinions on 182 medical device standard establishment projects and 125 standard draft for comments and their drafting instructions, with a public disclosure period of 1 month and 2 months respectively. We publicly released 94 pieces of relevant information on medical device standard project solicitation, member solicitation, standard approval meetings and other matters of each standard committee (technical competent authority), encouraging all parties to actively participate in the formulation and revision of medical device standards. We timely released the 2020 annual medical device standard publicity plan to increase the intensity of standard publicity. We timely responded to and handled 137 comments and suggestions fed back from the public feedback platform of the Standards Management Center. A mechanism for all relevant parties to extensively participate in the whole process of medical device standard formulation and revision has been established.