Author: Liu Changsheng Shi Yanping Hou Li

Source: China Food and Drug Net

 The National Technical Committee for Standardization of Biological Evaluation of Medical Devices (SAC/TC248, hereinafter referred to as TC248) is responsible for the formulation and revision of national standards and industry standards for biological evaluation of medical devices in China, and participates in the standardization work of its counterpart in the International Organization for Standardization (ISO)-Technical Committee for Biological and Clinical Evaluation of Medical Devices (ISO/TC194) on behalf of China. TC248 has been in preparation since the beginning of 1995, and the secretariat relies on Shandong Institute of Medical Devices and Pharmaceutical Packaging Inspection. In the process of preparation, TC248 closely follow the pace of international standards, comprehensively carry out the standardization work in the field of biological evaluation of medical devices. 2001, the first committee of TC248 was formally established.

 Since its establishment, TC248 has gone through 3 sessions, and its successive chairmen are Xi Tingfei, professor of Peking University, Zhang Xingdong, academician of Chinese Academy of Engineering, Liu Changsheng, academician of Chinese Academy of Sciences, of which Liu Changsheng is the current chairmen. The composition of the committee covers supervision, evaluation, inspection, scientific research, production enterprises and other related fields. Successive high-quality expert members have carried out a lot of fruitful work in the field of standardization of biological evaluation of medical devices in China.

 In recent years, the rapid development of China's medical device industry and the emergence of new materials, processes, technologies and products have brought opportunities for the standardization of biological evaluation of medical devices in China, as well as challenges to the regulatory work. Under the leadership of State Drug Administration, TC248 has made breakthrough progress in the field of medical device biological evaluation standardization by grasping the development opportunity of the industry, bearing the important responsibility of serving the supervision, strengthening the management of the committee, perfecting the standard system and strict workflow. 2021, TC248 was awarded as the first-level standardization technical committee by the State Standardization Administration Committee.

 Building a system and platform to achieve high-quality development of standardization work

TC248 attaches importance to the construction of the standard system, stays close to the frontier of development in the field of biological evaluation of medical devices, and adjusts the standard system according to the development of the industry at the right time. After more than 20 years of enrichment and improvement, TC248 has gradually built up a reasonable structure, clear hierarchy, coordinated and complementary standard system for biological evaluation of medical devices, which covers ten major standards, such as evaluation principles and general requirements for tests, biological test methods, physical and chemical tests, degradation tests and evaluations, physical and chemical tests and evaluations, preclinical animal studies for medical devices, and biological evaluations for specialized fields.

TC248 cooperates with Sichuan University, Shandong University and other universities and research institutes, giving full play to the technical advantages of the Key Laboratory for Safety Evaluation of Biomaterials and Devices of the State Drug Administration and the Biological Evaluation Branch of the Chinese Society for Biomaterials of the relying units, as well as the cooperation advantages of the Institute of Pharmaceutical Regulatory Science of Shandong University and the Biomaterials Cooperation and Innovation Platform, and focusing on the technological difficulties in the regulation of medical devices. We have carried out scientific research on a number of national and provincial research projects to enrich and improve the standard system for safety evaluation of new biomaterial devices, and strongly promote the high-quality development of standardization work.

 Transforming international standards to promote China's device industry to keep pace with the world

 It is one of the important tasks of TC248 to transform international standards in a timely manner to speed up the pace of international harmonization, and the GB/T 16886 series of standards for Biological Evaluation of Medical Devices is formed by transforming and updating the ISO 10993 series of standards in a timely manner. At present, GB/T 16886 series of standards covers the basic principles of biological evaluation of medical devices, biological test methods, sample preparation methods, physical and chemical characterization methods of medical devices, etc. It is an important document based on the biological test, biological evaluation and technical review of medical devices in China. Among them, GB/T 16886.1 “Biological Evaluation of Medical Devices Part 1: Evaluation and Tests in Risk Management Process” is a basic and programmatic document, which is a part of the GB/T 16886 series of standards, guiding the biological evaluation of medical devices in a more scientific and reasonable way, and reducing unnecessary waste of resources.

The implementation of GB/T 16886 series of standards has gradually improved the level of biological evaluation of medical devices in China, provided strong technical support for government supervision and technological innovation of manufacturers, played an important role in promoting the healthy development of China's medical device industry and its convergence with the international standards, and played a fundamental role in guaranteeing the safety of the public in China.

 Combining the national conditions and independent innovation to show the standard in development

TC248 extensively researches the key issues in the field of biological evaluation of medical devices, gives full play to forward-looking thinking, grasps the pulse of the industry, tracks the direction of industry development, communicates closely with the regulatory authorities, scientific research institutes and relevant manufacturers, etc., and accurately grasps the industry's demand for standardization in a timely manner, actively follows the research and development of new materials, methods and technologies, determines the committee's work priorities and adjusts the industry's hotspots on a rolling basis. The committee has determined the committee's work priorities and adjusted the industry's hotspots on a rolling basis, and increased the development of relevant standards in the core areas.

 Up to now, TC248 has independently formulated more than 50 national and industrial standards. Among them, GB/T 16175 “Test Methods for Biological Evaluation of Medical Silicone Materials” has filled the gap of methodological standards for biological evaluation of medical devices in China for many years before the release of GB/T 16886 series of standards, and played an important role in the development of China's medical device industry.

 In addition, TC248 also formulated YY/T 0870 “Genotoxicity Test for Medical Devices” series of standards, YY/T 0878 “Complement Activation Test for Medical Devices” series of standards, YY/T 0771 “Medical Devices of Animal Origin” series of standards, YY/T 1292 “Reproductive and Developmental Toxicity Test for Medical Devices” series of standards, YY/T 1465 “Medical Device Immunogenicity Evaluation Methods for Medical Devices, YY/T 1649 Interaction Tests for Medical Devices and Platelets, YY/T 1754 Preclinical Animal Research for Medical Devices, YY/T 1806 Evaluation Methods for In Vitro Degradation of Bio-medical Materials, and YY/T 1812-2022 Characterization of Physical and Chemical Properties of Degradable Bio-medical Metallic Materials, and so on. These industry standards are important supplements to the national standards. These industry standards are important supplements to national standards, which make the biological evaluation of medical devices more operable, improve the level of biological evaluation of medical devices in China, provide strong technical support for scientific supervision by regulatory authorities and technological innovation of enterprises, and play an indispensable role in the healthy development of China's medical device industry and its convergence with the international market.

 Participating in international standardization work and delivering China's voice to the world

 As the domestic technical counterpart of ISO/TC194, TC248 actively participates in the formulation and revision of international standards related to ISO/TC194, and has participated in the formulation and revision of 6 international standards so far. Among them, TC248 has co-drafted ISO 10993-3 “Biological Evaluation of Medical Devices Part 3: Genotoxicity, Carcinogenicity and Reproductive Toxicity Tests” (in progress) and ISO/TS 37137-1:2021 “Biological Evaluation of Absorbable Medical Devices Part 1: General Provisions” (completed); participated in ISO 10993-4:2017 “Biological Evaluation of Medical Devices Part 4 : Selection of tests for interaction with blood (completed), ISO 10993-23:2021 “Biological evaluation of medical devices Part 23: Stimulation test” (completed), ISO 10993-5 “Biological evaluation of medical devices Part 5: In vitro cytotoxicity test” (in progress) and ISO 10993-10 “Biological evaluation of medical devices Part 10: Skin Sensitization Test” (in progress) test protocol development and validation work.

 In addition, TC248 also hosted the ISO/TC194 Annual International Standardization Conference and Workshop and the International Forum on Quality and Safety Evaluation of Medical Devices and Biomaterials in 2009 and 2019, respectively, and was qualified to host the next Annual International Standardization Conference. Through international academic exchanges, we have enhanced mutual understanding with international standardization organizations and increased the visibility of China's medical device standards and technologies in the international arena.

TC248 represents China's substantive participation in the international standardization and revision work, which further strengthens China's international discourse in related fields and is of great significance in promoting China's medical device biological evaluation and even medical device industry to be in line with the international standards.

 Linkage of standards and technology leads the innovation and development of medical device industry

TC248 closely focuses on the national strategic needs, bases on the actual development of biomaterials field, combines with scientific research topics, and strengthens the basic research work of standardization. In recent years, TC248 has actively presided over or participated in the projects of the National Science and Technology Support Program of the 12th Five-Year Plan, the National Key R&D Program of the 13th Five-Year Plan, as well as the projects of “Characterization and Safety Evaluation of New Materials”, “Safety Evaluation of New Materials” and “Standardization of Medical Devices” under the Action Plan for Drug Regulation in China. Safety Evaluation”, ‘Research, Transformation and Evaluation of Innovative Medical Biomaterials’, etc. We innovate regulatory tools, standards and methods, and promptly transform the research results into national standards or industry standards to help solve the outstanding problems affecting and restricting the innovation and high-quality development of medical devices.

 In the “13th Five-Year Plan” National Key R&D Program “Key Technology Research on Safety and Molecular Marking of New Biodegradable Biomaterials”, TC248 has solved the technical difficulties in the evaluation of new biomaterials, determined the evaluation technology of key performance indicators, and completed more than ten methodological industry standards. In 2018, the scientific research achievement “Application of Biological Evaluation Standards and Key Testing Technologies for Medical Devices and Materials” won the second prize of Shandong Science and Technology Progress Award.

 Establishing the sense of service and creating the “golden signboard” of the committee

TC248 has always taken service regulation and industry as its guiding ideology, and through its effective work, it has gained the high attention of government departments and the industry, established its prestige and created a “gold standard”.

 After the release of the relevant standards, TC248 timely organization and convening of standard publicity meetings, supervision, evaluation, inspection, production enterprises and other areas of personnel to carry out publicity. Since its inception, TC248 organized dozens of classes, the number of students reached thousands of people, effectively promoting the implementation of standards. In addition, TC248 also organizes expert members to prepare “Guidelines for the Implementation of Biological Evaluation Standards for Medical Devices”, “Biocompatibility Evaluation of Medical Devices and Materials”, etc., to further promote and enhance the level of biological evaluation of medical devices in China.

 Next, TC248 will continue to be based on serving government supervision and promoting industrial development, further strengthen the management and construction of the Technical Committee, follow the needs of scientific supervision and the development of domestic and international medical device biological evaluation field, and constantly improve the standard system; conduct extensive research, establish projects in a timely manner, and strictly carry out the procedural requirements for standardization and revision to develop and revise more high-quality national standards and industry standards, and strive to keep the medical device biological evaluation standards in line with the international standards and standards. The biological evaluation standards of medical devices keep pace with the international standards, provide support for scientific supervision, and help the high-quality development of China's medical device industry.

 Improve the political position, standardization work to bring greater health benefits to the people

 TC248 will continue to take “people first, life first” as the starting point of medical device standardization work, implement the National Standardization Development Outline (hereinafter referred to as “Outline”) and the “Fourteenth Five-Year Plan”, and make efforts to make China's medical device biological evaluation standards keep pace with the international standards and support scientific regulation. National Standard Development Program (hereinafter referred to as the “Program”) and the “14th Five-Year Plan for the Construction of National Standard System to Promote High-Quality Development”, and will continue to study and improve the standard system, and be the leader and innovator of the standard in the field of counterparts.

TC248 will actively respond to the “Opinions on Further Promoting the High-Quality Development of Medical Device Standardization” of the State Drug Administration and the State Standardization Administration, which proposes to “strengthen the research on standards for new biomedical materials, and promote the formulation and revision of standards for new technologies, processes, and materials such as combination products of medicines and devices, augmentation materials manufacturing, biodegradable materials, tissue engineering materials, recombinant collagen materials, and nano-materials”. To carry out research on the characterization of hazardous substances and toxicological evaluation methods and the formulation of standards” and ‘to establish a standard system for preclinical animal testing’, closely focusing on the regulation of medical devices and industrial development. The company will continue to optimize the standard system and rationally plan the layout of the biological evaluation standard system, so as to serve the life and health safety of the people with more rigorous standards and bring greater health benefits to the people through standardization work.

 Deep plowing quality and scientific supervision, and do a good job in technical support

 Quality supervision is a necessary means to promote the strategy of a strong quality country, and standards play a supportive, strategic and fundamental role in the strategy of a strong quality country.TC248 Relying Unit is one of the national medical device inspection organizations, and also owns three key laboratories of the State Drug Administration, which plays a very important technical support role in the supervision of medicines and devices. With the support of the relying unit, TC248 will continue to promote the work of the Technical Committee, provide technical support for the relying unit to implement the standardization development strategy, provide technical support and basic guarantee for the quality of the country, and contribute to the wisdom of promoting the rational optimization of the structure of the medical device industry and scientific and technological innovation.

 Continuous standardization innovation, strengthen the inner driving force of standard development

 In the fierce international competition, only the innovator is strong and only the innovator wins.TC248 will continuously adapt to the current changes in social development, continue to innovate, and achieve high-quality development in innovation; continuously improve the standardization management system for high-quality development, and follow up the standardization work in a timely manner around the achievements of independent innovation of medical devices, so as to provide support and guarantee for the innovation of the industry; and continuously develop new technologies around basic and applied research, new standards and methods, and strive to strengthen the inner driving force of standard innovation.

 Actively participate in international standardization activities to improve the quality and competitiveness of China's standards

 Implementing the standardization strategy is the top priority of China's standardization work, TC248 will continue to implement the spirit of the Outline, make good use of the support policies of the state and the competent departments for the development of standards, pay close attention to and take the initiative to participate in the international standardization activities, and strive for the co-development and leading development of international standards. At the same time, TC248 will promote the upgrading of the medical device industry by comprehensively upgrading the standards, promote the formation of new competitive advantages, promote China to leap from a big country to a strong country in the manufacture of medical devices, enable China's medical device industry to win the initiative in the international competition, and grasp the right to formulate the international rules of the industry, and gradually set up and continuously strengthen the status of China's medical device industry in the world economy.

 People-oriented, create excellent talent team

 Gradually upgrading the standardization activities can not be separated from the high-quality standardization professional talent team.TC248 will continue to improve the level of the team on the basis of the current high-quality composite talent team, constantly replenish the fresh blood, and build a reasonable talent team echelon; improve the system to ensure that standardization of talent training as a long-term work, and gradually optimize the mechanism, the establishment of international standardization of talent training plan; Continuously strengthen the cooperation with all relevant institutions in China and the working exchanges with international organizations, create opportunities for China's standardization professionals to participate in international conferences and go abroad for further study, and encourage them to learn in-depth knowledge of standardization and improve the level of practical work.

 The new era has given the standardization work a new normal, which is both a challenge and an opportunity. tc248 will be based on the overall deployment of the standardization work and the target tasks of the State Drug Administration, strengthen the new