本期概览

Abdullozoda Said Murtazo is a Tajik Doctor of Medical Science and Professor of Epidemiology at Avicenna Tajik State Medical University. He currently serves as Head of the Educational and Methodological Department and works as an International Accreditation Expert. Holding the Ismoil Somoni State Prize, he owns extensive experience in epidemiological teaching, biomedical laboratory research, university HR administration and medical education digitization. Fluent in Russian and English, he devotes himself to improving medical curriculum standards, digital teaching reform and international higher education quality evaluation in Tajikistan.

Khuseyn Nazarzoda is a PhD-qualified Public Health & Environmental Health specialist, Associate Professor and Head of International Relations at Avicenna Tajik State Medical University. Holding an MPH from Tehran University of Medical Sciences and joint Erasmus Plus doctoral training in Estonia, he has over 12 years of experience in epidemiological research, university teaching and global health project management. He has managed dozens of donor-funded projects for WHO, USAID, World Bank, UNICEF and EU Erasmus Plus programmes, published more than 40 scientific papers, and participated in international health expert missions across Europe and Central Asia. Fluent in multiple regional and international languages, he leads the university’s global partnership strategy, student exchange schemes and cross-border medical education cooperation, focusing on environmental health, disease prevention and health system capacity building in Tajikistan and Central Asia.

Mahdi Borhani Zarandi is a Distinguished Professor of Parasitology at Xinjiang Medical University, China, holding a PhD in Parasitology and postdoctoral training in hydatid disease research from Iran. With over 15 years of experience in zoonotic parasitology, laboratory diagnostics and university teaching, his core research covers echinococcosis, leishmaniasis and helminth immunology, supported by more than 35 international journal publications. He previously conducted research at Jilin University and Iran’s leading hydatid disease research centre, specialising in molecular parasitology, field epidemiology and experimental parasitic disease models. He undertakes China national key laboratory research projects and frequently serves as an invited speaker at international zoonosis conferences, advancing Sino-Iran collaborative research on parasitic disease prevention and control in Central Asia.

骆庆峰，医学博士，研究员。第六届全国医用体外循环设备标准化技术委员会委员兼副秘书长。完成制定血液透析浓缩物、血液透析管路、膜式氧合器等超过15项体外循环和血液净化产品的注册申报指导原则，参与并提议制定多项行业标准。
Luo Qingfeng, Ph.D. in Medicine, Researcher. Member and Deputy Secretary-General of the Sixth National Technical Committee for Standardization of Medical Extracorporeal Circulation Equipment. Has completed the formulation of registration guidance principles for over 15 extracorporeal circulation and blood purification products, including hemodialysis concentrates, hemodialysis circuits, and membrane oxygenators, and participated in proposing multiple industry standards.

上海长征医院骨科医院院长、全军骨科研究所所长、上海市重中之重脊柱疾病临床医学中心主任、上海市骨科临床医学研究中心主任、国务院政府特殊津贴/军队优秀技术人才一类岗位津贴、上海市十大科技精英/首届上海杰出人才、上海市十佳医生/国之名医卓越建树奖、上海市领军人才/上海市优秀学科带头人、中国医师协会脊柱肿瘤专委会主任委员、中华医学会骨科分会常委/脊柱肿瘤学组组长、中国抗癌协会肉瘤专业委员会候任主任委员、全军骨科专委会副主任委员
以第一或通讯作者在Journal of Clinical Oncology、Nature Medicine, Lancet 0ncology,JBJS等杂志发表SCI论文300余篇
以第一完成人获得国家科技进步二等奖1项、省部级一等奖6项、上海国际高端医疗器械创新大赛特等奖1项、何梁何利基金科学与进步奖、光华工程科技奖
科技部重点研发项目首席科学家/首届东方英才创新团队计划首席科学家
主持国家自然科学基金重点项目、军队重点项目、上海市重大课题等40余项

卢忠，制药高级工程师，经济学研究生。现任中国药品监管研究会医疗器械专委会副主任委员。2002年以来，先后从事医疗器械质量监督检验检测、医疗器械技术审评工作、医疗器械创新审查、医疗器械监管政策及产业经济研究等工作。历任国家药监局广州医疗器械质量监督检验中心主任，国家药监局医疗器械技术审评中心党委副书记、副主任，国家药监局南方医药经济研究所所长职务。主编《中国医疗器械产业发展报告（现状及十四五展望）》，主编国家药监局医疗器械审评规范丛书《无源医疗器械注册技术审评指导原则》等。

北京天恒同业资产管理有限公司董事长，北京药品登记信息服务有限公司董事、总经理，北京极数宝健康科技有限公司董事长。

聂洪鑫，山蓝资本管理合伙人，中国生物材料学会副理事长、产学研工作委员会主任委员、《生物材料与医疗器械》副主编、《现代仪器与医疗》杂志编辑委员会委员，担任教育部医用生物材料工程研究中心第二届技术委员会委员、中国科协“科创中国”平台入住产业界及经济界双重专家，科技部中国医疗器械创新创业大赛多届决赛专家评委，在医疗器械领域有着丰富的孵化运营、上市并购及产业整合经验。荣获中国医疗健康投资卓悦榜 2019、2020年度最佳投资人，2021年度中国医疗大健康产业最具影响力TOP50投资人，2022年被母基金评选为最具潜力直投基金投资人TOP30，2023年被母基金评选为最佳医疗健康领域投资人TOP20，2024年最具潜力女性直投基金投资人等荣誉。
Hongxin Nie is a managing partner at Sunland Capital; Vice Chairman of the Chinese Society for Biomaterials; Associate Editor of Biomaterials and Medical Devices; Member of the Editorial Board of Modern Instruments and Medicine. Dr. Nie serves on the Second Technical Committee of the Engineering Research Center for Medical Biomaterials under the Ministry of Education, and is a dual expert of both industrial and economic sectors on the “Science and Innovation China” platform under the China Association for Science and Technology. Dr. Nie has been a final judge for multiple editions of the China Medical Device Innovation and Entrepreneurship Competition hosted by the Ministry of Science and Technology. Dr. Nie’s industry accolades include: Top Investor of the Year (2019 & 2020) from the China Healthcare Investment Excellence Awards; Top 50 Most Influential Investors in China’s Healthcare Industry (2021); Top 30 Most Promising Direct Investment Fund Investors (2022); Top 20 Best Healthcare Investors (2023, selected by domestic FOFs); and Top Promising Female Direct Investment Fund Investor (2024).

张威鹏，深圳市市场监督管理局许可审查中心医疗器械审评认证部 部长 ，国家药品监督管理局高级研修学院讲师、广东省医疗器械标准化技术委员会委员、广东省药品监督管理局医疗器械生产质量管理规范检查员（组长）。

GHWP（中国）学院客座教授，
前GHWP副主席，
前百特亚太法规与质量副总裁
Guest Professor of GHWP（China）Academy，Former GHWP Vice-Chair (Industry), Former Vice President of QA/RA (APAC) Baxter International Inc

鞠珊，国家药监局器审中心临床与生物统计一部审评员，副研究员。主要从事国产III类及进口医疗器械临床评价技术审评工作。

Ju Shan. Reviewer of the Clinical and Biostatistics Department I, Center of Medical Device Evaluation, National Medical Products Administration. Associate Researcher. Primarily engaged in the technical review of clinical evaluations for domestic Class III and imported medical devices.

张世庆
国家药品监督管理局医疗器械技术审评中心
质量管理部部长
审评互信实践特别工作组主席
Zhang Shiqing
Director of Quality Management Division,
Center for Medical Device Evaluation,
National Medical Products Administration.
Chair of CERP STG



张世庆，研究员，军事医学科学院理学博士，现任职于国家药监局医疗器械技术审评中心质量管理部。
Zhang Shiqing,Researcher, Doctor of Science from the Academy of Military Medical Sciences. He is currently working in the Quality Management Division, Center for Medical Device Evaluation, National Medical Products Administration.

李军
国家药监局医疗器械技术审评中心 副主任；
GHWP 技术委员会主席。
Deputy Director of the Center For Medical Device Evaluation, National Medical Products Administration.
GHWP TC Chair.

彭亮
工学博士，国家药监局医疗器械技术审评中心审评一部副部长，国家级检查员。执笔软件、网络安全、移动与云计算、深度学习与人工智能、人因与可用性等审评指导原则，以及GMP独立软件附录及其检查指导原则。

Liang Peng, PhD, is the Deputy Director of Department Ⅰ of the Center for Medical Device Evaluation (CMDE), National Medical Products Administration (NMPA), and also a national inspector. He drafted the review guidelines of software, cybersecurity, mobile and cloud computing, deep learning and artificial intelligence, human factors and usability, as well as the GMP SaMD appendix and its inspection guideline.

地24批中组部团中央博士团成员，担任中国医师协会骨科青年工作组副组长、上海合作组织卫生可持续发展工作委员会副秘书长、中国医学装备协会医疗器械创新与应用分会副会长、上海临港产业大学医疗装备骨科专业学院院长等社会职务，目前正在整合多方平台力量，致力于推动中国医疗产业国际化。年主刀高难度脊柱外科和骨肿瘤手术200余台。获得授权专利14项。以第一或通讯作者发表SCI论文16篇。完成医学独著1部，获上海人才发展资金，入选2023东方英才计划青年项目等人才项目。近年来以主要完成人获得中华医学科技奖一等奖、第三届“海聚英才”全球创新创业大赛铜聚奖、2024 MDinno上海（国际）高端医疗器械创新大赛特等奖等奖项。

主讲人介绍：
韩昭昭，国家药品监督管理局医疗器械技术审评中心审评六部副部长。长期承担体外诊断试剂及设备的注册申报资料技术审评工作，组织开展体外诊断领域相关技术指导原则的编制与实施工作，参与医疗器械监管相关技术研究与行业规范制定。

Biography:
HAN ZHAOZHAO，Deputy Division Chief, Division 6, Center for Medical Device Evaluation, National Medical Products Administration. Responsible for reviewing the registration documents of In Vitro Diagnosis Device, including in vitro diagnostic reagents and instrument. Organize the writing and implementation of relevant technical guidelines.

主讲人介绍：
宋德伟 博士/研究员，中国计量科学研究院 临床与药物化学计量研究室主任，临床诊断与药物计量技术创新团队带头人，哈尔滨工业大学兼职博士生导师，国家一级注册计量师，现任全国仪器分析测试标准化技术委员会（SAC/TC481）秘书长，全国临床医学计量技术委员会（MTC21）秘书长，国际物质量咨询委员会（CCQM）蛋白质工作组中国技术专家、亚太计量合作组织（APMP）物质量技术委员会中国代表、国际检验医学溯源联合委员会（JCTLM）蛋白质评审专家。长期从事检验医学溯源与标准化工作，主持十四五国家重点研发计划、十三五国家质量基础重大专项（NQI）、十二五863项目、国家科技支撑计划等多项科研项目，获得北京市科技进步一等奖1项、中国分析测试协会特等奖2项，中国计量测试学会一等奖1项。完成国际比对6项，制定国家标准6项，起草国家计量技术规范8项，研制重大疾病国家一级标准物质21项、二级标准物质11项。第1发明人获得国家授权发明专利10项，主编论著2部，在Clin Chem，Anal. Chem， Clin Chem Lab Med，Anal Bioanal Chem，Biosensors and Bioelectronics等杂志发表论文100余篇。

Biography:
Dr. Dewei Song is a Senior Researcher at the National Institute of Metrology, China, where he serves as Director of the Laboratory of Clinical and Pharmaceutical Chemical Metrology and leads the Innovation Team for Clinical Diagnostics and Pharmaceutical Metrology. He is also an adjunct doctoral supervisor at Harbin Institute of Technology and a National Class-I Certified Metrology Engineer.

Dr. Song currently serves as Secretary-General of the National Technical Committee on Instrumental Analysis and Testing of the Standardization Administration of China (SAC/TC481) and Secretary-General of the Chinese Joint Committee for Traceability in Laboratory Medicine (CJCTLM). He is also a Chinese technical expert in the Protein Analysis Working Group of the Consultative Committee for Amount of Substance: Metrology in Chemistry and Biology (CCQM), China’s representative to the Technical Committee for Amount of Substance of the Asia Pacific Metrology Programme (APMP), and a protein review expert for the Joint Committee for Traceability in Laboratory Medicine (JCTLM).

主讲人介绍：
王涵，博士，中国药品检定研究院副研究员。主要研究方向为医疗器械产品安全有效性评价及标准化。现任中国生物材料学会整复生物材料分会委员、北京环境诱变剂学会检验检测分会理事。作为标准起草人参与起草医疗器械国家标准2项、行业标准1项、团体标准4项。作为课题负责人承担中国药品监督管理研究会课题1项、中检院青年基金1项。作为项目主管参加工信部项目1项，作为课题骨干参加国家重点研发专项4项，中科院先导专项1项。以第一作者及通讯作者发表论文25篇，其中SCI论文11篇。

Biography:
Dr. Han Wang is an Associate Researcher at National Institutes for Drug Control (NIDC). Her primary research focuses on safety and efficacy evaluation and standardization for medical devices. She currently serves as a member of the Reconstructive Biomaterials Subcommittee of the Chinese Society for Biomaterials, and a council member of the Inspection and Testing Branch of the Beijing Society of Environmental Mutagens. As a standards drafter, she has participated in the development of 2 national standards, 1 industry standard, and 4 group standards for medical devices. As principal investigator, she led one project for the China Society for Drug Regulation and one NIDC Youth Fund project. As project manager, she participated in one project of the Ministry of Industry and Information Technology. As a key research member, she contributed to four National Key R&D Programs and one Strategic Priority Research Program of the Chinese Academy of Sciences. She has published 25 papers as first or corresponding author, including 11 SCI-indexed papers.

主讲人介绍：
张学慧，教授、博导，国家优青，北京大学口腔医院口腔材料研究室主任、北京大学口腔医学院口腔医疗器械检验中心主任、全国口腔材料和器械设备标准化技术委员会秘书长、国家药监局监管科学创新研究基地主任。研究方向为口腔新材料研发与评价。作为项目负责人承担科技部重点研发计划课题、国家自然科学基金面上项目等17项，牵头制修订国行标10余项，以通讯作者在Science Advances、Nature Communications、Advanced Materials等期刊发表SCI论文50余篇，获授权国内外发明专利30余项，获教育部科技进步一等奖、中华口腔医学科技奖一等奖、科技部全国颠覆性技术创新大赛最高奖等。兼任中国食品药品企业质量安全促进会副会长、中国实验动物学会屏障医学专委会常务委员、中华口腔医学会口腔材料专委会委员、中国生物材料学会生物复合材料分会委员、北京口腔医学会口腔材料专委会副主任委员等。
Biography:
Xuehui Zhang, Professor and Doctoral Supervisor, is a recipient of the National Science Fund for Excellent Young Scholars. He serves as Director of the Department of Dental Materials, Peking University School and Hospital of Stomatology; Director of the Dental Medical Devices Testing Center of Peking University School of Stomatology; Secretary-General of the National Technical Committee on Dental Materials, Instruments and Equipment (SAC/TC 99); and Director of the NMPA Regulatory Science Innovation Research Base (Medical Devices).
His research focuses on the development and evaluation of innovative dental materials. As principal investigator, he has led 17 research projects, including projects funded by the National Key Research and Development Program of China and the General Program of the National Natural Science Foundation of China (NSFC). He has also led the development and revision of more than 10 national and industry standards.
Professor Zhang has published more than 50 SCI-indexed papers as corresponding author in leading journals, including Science Advances, Nature Communications, and Advanced Materials, and has been granted more than 30 invention patents in China and abroad. His research and technological innovations have received several major awards, including the First Prize of the Science and Technology Progress Award of the Ministry of Education of China, the First Prize of the Science and Technology Award of the Chinese Stomatological Association, and the highest award in the National Disruptive Technology Innovation Competition organized by the Ministry of Science and Technology.
He also serves as Vice President of the China Association for Quality and Safety Promotion of Food and Drug Enterprises, Standing Committee Member of the Barrier Medicine Committee of the Chinese Association for Laboratory Animal Sciences, Member of the Dental Materials Committee of the Chinese Stomatological Association, Member of the Biocomposites Branch of the Chinese Society for Biomaterials, and Vice Chair of the Dental Materials Committee of the Beijing Stomatological Association.

主讲人介绍：
郑佳，中国药品检定研究院医疗器械标准管理研究所副所长，长期从事医疗器械标准、分类研究工作。

Biography:
英文版介绍
Deputy Director of the Institute for Medical Device Standard Administration, National Institutes for Drug Control (NIDC), with long_x001e_term involvement in research on medical device standards and classification.

主讲人介绍：
韩倩倩，研究员，硕士生导师，中国药品检定研究院 医疗器械检定所所长，医学人工智能产品标准化与测试验证北京市重点实验室主任。IEC/TC62/SC62D/JWG35、36手术机器人和康复机器人专家；医疗器械生物学评价标准化技术委员会SAC/TC248副主任委员；医用增材制造医疗器械标准技术归口专家组副组长；国家药监局医疗器械分类界定委员会委员、医疗器械技术审评专家咨询委员会成员；中国生物材料学会常务理事。从事医疗器械临床前安全性有效性评价方法和生物材料毒理学研究。主持十三五、十四五科技部重点研发计划课题，国家药监局监管科学行动计划项目，中国科学院战略性先导科技专项等课题8项。在Biomaterials, Bioactive Materials,journal of controlled release等期刊发表论文五十余篇，参与编著专著4部，制定医疗器械国家行业标准二十项。
Biography:
Biography:
Dr. Qianqian Han is a Research Fellow, Master’s Supervisor, and Director of the Medical Device Testing Institute at the National Institutes for Drug Control (NIDC). She also serves as Director of the Beijing Key Laboratory of Standardization, Testing and Verification for Medical Artificial Intelligence Products. She is an expert on IEC/TC62/SC62D/JWG35 and JWG36 (Surgical and Rehabilitation Robots), Vice Chairman of the Standardization Technical Committee for Biological Evaluation of Medical Devices (SAC/TC248), Deputy Convener of the Expert Panel on Medical Additive Manufacturing Device Standards, and a member of both the NMPA Medical Device Classification Committee and the Expert Advisory Committee for Medical Device Technical Review. Additionally, she is an Executive Council Member of the Chinese Society for Biomaterials. Her research focuses on preclinical safety and efficacy evaluation methods for medical devices and toxicological studies of biomaterials. She has led eight major research projects, including National Key R&D Program projects during the 13th and 14th Five-Year Plans, NMPA Regulatory Science Action Plan projects, and the CAS Strategic Priority Research Program. She has published over 50 papers in leading journals such as Biomaterials, Bioactive Materials, and the Journal of Controlled Release, co-authored four monographs, and developed twenty national and industry standards for medical devices.

美国田纳西大学（University of Tennessee）、范德堡大学（Vanderbilt University）博士后研究员
美国Laboratory Corporation of America Holding（LabCorp）高级细胞遗传学技术专家
持有美国临床病理学会（ASCP）颁发的细胞遗传学技术专家（CG）资格证书
北京热景生物技术股份有限公司国际体外诊断（IVD）医学总监
白求恩精神研究会检验医学分会常务理事

研究员
中国药品监督管理研究会秘书长、常务理事
信息化专委会副主任委员