department of medical devices supervision and
TRANSCRIPT
Department of Medical Devices Supervision and Administration
National Medical Products Administration (NMPA)
http://www.nmpa.gov.cn
The China NMPA is responsible for post-market supervision and management of medical devices. NMPA
includes regulatory departments at all levels to supervise more than 17,000 medical device manufacturing
enterprises and 500,000 medical device enterprises operating in China. NMPA organizes, formulates and
supervises the implementation of quality management standards for the production of medical devices in
accordance with their duties. They organize, formulate and guide the implementation of quality management
standards for the operation and use of medical devices. They undertake the job of organizing and guiding on-site
inspection of production and organizing the investigation and punishment of major illegal acts. They arrange
random quality inspections and issue quality announcements regularly. They organize and carry out monitoring
of adverse events and handle them appropriately, according to law.
The post-market supervision of medical devices has formed a three-level regulatory system of laws, regulations
and normative documents, covering the whole cycle of production, circulation and use of medical devices. They
organize and supervise the implementation of Regulations on Supervision and Administration of Medical
Devices, Measures for Supervision and Administration of Medical Device Production, Measures for Supervision
and Administration of Medical Device Operation, Measures for Supervision and Administration of Medical
Device Use Quality, Measures for Management of Medical Device Recall, and Measures for Management of
Medical Device Adverse Events and Re-evaluation, etc.
The Regulations on the Supervision and Administration of Medical Devices is in the process of revision. They
have a plan to further stimulate market vitality, strengthen risk management of medical devices and ensure safety
of medical devices. Relevant supporting management regulations, such as Measures for Registration of Medical
Devices, Measures for Supervision and Administration of Medical Device Production, Measures for Supervision
and Administration of Medical Device Management, and Measures for Supervision and Administration of
Medical Device Use Quality, will also be revised in accordance with the progress of amendments to regulations.
Some key areas of interest for NMPA would help them address the problem of social aging in China, which is
becoming more and more serious, and with the implementation of the ‘Healthy China’ strategy, the demand for
advanced medical devices in the United States will be increasing in the Chinese market.
The supervision of medical devices is mainly under the responsibility of two divisions (Department of Medical
Device Registration and Department of Medical Device Supervision) set up by NMPA. The directly affiliated
departments of NMPA, such as the Central Procuratorate, the Verification Center, the Evaluation Center and the
Device Examination Center, provide corresponding technical support.
DELEGATE BIOGRAPHIES*
WANG Zhexiong
Director General
Department of Medical Device Supervision, NMPA
Mr. WANG graduated from the Department of Pharmacy, Shenyang Pharmaceutical
University, with a master’s degree in Public Administration, Peking University.
Since 1986, Mr. WANG has been in charge of supervision and management of
pharmaceutical products, including the supervision and administration of drug safety,
inspection, pre-market registration and post-market supervision of medical devices. He
participated in the revision of the Drug Administration Law and organized the drafting
and revision of many important drug administration regulations, such as the Standards for the Quality Control of
Drug Production. He participated in the revision of Regulations on the Supervision and Administration of Medical
Devices and organized the drafting of some content. He also drafted and revised many important supporting
regulations and normative documents for medical devices, such as Standards for Quality Management of Medical
Device Production, Management Measures for Monitoring and Re-evaluation of Adverse Events of Medical
Devices, and Guiding Principles for Clinical Evaluation Technology of Medical Devices.
Delegate Interests:
Mr. WANG’s goals for this visit are to fully learn from the advanced experience of the United States in
medical device supervision. He also hopes to learn how to build a more effective medical device safety
management system, improve risk management, strengthen the implementation of responsibility, promote
intelligent supervision, and further increase the scientific, legal, international and modern level of
supervision.
He is specifically interested in learning more about ideas and regulation for the continuous risk assessment
on post-market medical devices, as well as the collection, declaration and management of adverse events.
He is most interested in learning more about technologies in the following areas: inspection of quality
management system, collection, reporting and management of adverse events, and management of imported
medical devices. He is also interested in learning more about intellectual property protection and the FDA's
cooperation with customs and judicial departments.
MA Zhongming
Division Director
Division II, Department of Medical Device Supervision, NMPA
As the director of Division II, Department of Medical Device Supervision, Mr. Ma is
responsible for organizing the formulation of regulatory system and quality
management standards governing the manufacturing of IVD reagents and clinical
testing devices, and for their implementation. He also organizes onsite inspections for
major violations in the manufacturing process. Mr. Ma graduated from Beijing
College of Chinese Medicine.
Delegate Interests:
Mr. MA’s goals for this visit are to learn about the regulatory theories and rules governing device distributors
and users. He also hopes to learn more about the regulatory concepts and requirements for online sale of devices
and cross-border e-commerce import of devices. Finally, he hopes to learn about the regulatory theories and
rules for IVD reagents, and the training of inspectors in this area. He is particularly interested in learning about
e-commerce importing and retailing of medical devices, and IVD reagents.
ZHAO Bin
Deputy Division Director
Comprehensive Division, Department of Medical Device Supervision, NMPA
Ms. ZHAO received her postgraduate degree. She graduated from the School of
Pharmacy, Peking University. She is currently working in post-market supervision of
medical devices, and responsible for research on the supervision system of medical
devices and the analysis of safety situations.
Delegate Interests:
Ms. ZHAO’s goals for this visit are to fully learn from the advanced experience of the United States in
medical device supervision. She also hopes to learn how to build a more effective medical device safety
management system, improve risk management, strengthen the implementation of responsibility, promote
intelligent supervision, and further increase the scientific, legal, international and modern level of
supervision.
She is specifically interested in learning more about ideas and regulation for the continuous risk assessment
on post-market medical devices, as well as the collection, declaration and management of adverse events.
She is most interested in learning more about technologies in the following areas: inspection of quality
management system, collection, reporting and management of adverse events, and management of imported
medical devices. She is also interested in learning more about intellectual property protection and the FDA's
cooperation with customs and judicial departments.
LI Lu
Deputy Consultant
Division of Legislation, Department of Policy and Legislation, NMPA
Ms. LI is currently performing legislative work on drugs, medical devices and
cosmetics, including organizing the drafting of regulatory laws and regulations, as
well as the draft regulations of the department, and undertaking the legitimacy
review of normative documents. She graduated from the Law School of Shandong
University, with a master’s degree in Criminal Law.
Delegate Interests:
Ms. LI’s goal for her visit is to understand the regulatory system of medical devices in the United States and the
latest changes in regulations.
Some of the topics she is most interested in learning about is the division of responsibility, the undertaking of
legal responsibility and the responsibility of supervision departments of each main body of medical devices, etc.
She is also interested in learning how to encourage the innovation of medical devices. She would also like to
know how to classify and supervise medical devices and the supervision system of combination products, etc.
She would like to learn more about artificial intelligence, 3D printing and genetic detection technologies and
products.
BIAN Xu
Deputy Division Director
Division II, Department of Medical Device Registration, NMPA
Mr. BIAN is responsible for preparing administrative regulations on the clinical trial of
medical devices and quality administration specifications, as well as supervising
implementation. The Department of Medical Device Regulation is responsible for
registration of passive medical devices and approval of clinical trials on highly risky
passive medical devices. The Department of Medical Device Regulation also organizes
and conduct on-site inspections and research on the production of relevant products.
He graduated with Bachelor of Engineering degree in Control Technology and Instruments from the College of
Precision Instrument and Optoelectronic Engineering at Tianjin University. He received a Master of
Engineering in Bioengineering from Tsinghua University School of Medicine as an on-job postgraduate.
Delegate Interests:
Mr. BIAN’s goal is to learn about regulations on medical device classification and registration of FDA in the
U.S. He is particularly interested in learning about medical device registration and regulation (design,
transformation, production and inspection). While on this visit he hopes to see the production of passive and
sterile medical devices. He has interest in the following technologies: 3D printing, medical-industrial
interaction, and reuse of disposables.
WU Yinan
Deputy Division Director
Comprehensive Division, Department of Science, Technology and International
Cooperation, NMPA
Ms. WU is currently in charge of international cooperation in science and technology,
and cooperation with the U.S. Previously she worked in the cooperation of related
projects between the Gates Foundation and the NMPA, as well as the organization of the
meeting between Gates and leaders. She has a master’s degree in Public Policy.
Delegate Interests:
Her goal for this visit is to have a comprehensive understanding of the practice of medical device supervision in
the U.S. and establish working contacts of international exchanges. She is specifically interested in learning
more about the inspection of overseas medical devices carried out in the U.S., as well as learning more from
U.S. medical device manufacturers.
MU Ruihong
Deputy Division Director
Medical Device Standard Division, National Institute for Food and Drug Control,
NMPA
Ms. MU is responsible for the research of standard management, classification and
naming of medical devices, as well as the definition of management attributes of
combination products.
She has a rich experience in dental material research, quality testing and standard
preparation of medical devices. She participated in the drafting of regulations and
documents such as classification rules for medical devices. She is responsible for and participated in many
national-level projects such as national science and technology support projects. Her main area of research is
quality control and standardization of passive medical devices.
She has a Bachelor of Arts from Tianjin University and a Master of Engineering from Tianjin University.
Delegate Interests:
Her goals for this visit are to understand the classification and naming of medical devices and the role of
standards in the supervision of medical devices and the requirements for the supervision of combination
products.
She is interested in learning about the main contents of unclassified products and how FDA regulates
unclassified products. She is also interested in the regulatory requirements for additive manufacturing products
and tissue engineering products. She is also interested in the Clinical and Laboratory Standards Institute (CLSI)
and learning more about the relationship between IVD product quality control standards and EP standards.
SHI Lei
Deputy Director General
Center for Food and Drug Inspection, NMPA
As the Deputy Director General of the Center for Food and Drug Inspection, Mr. Shi is
responsible for regulating vaccines, medical devices and cosmetics. He has a medical
degree and is a physician by training.
Delegate Interests:
Mr. SHI’s goal for the visit is to gain a detailed understanding of on-site inspection methods of medical devices
in the U.S. He is particularly interested in learning about the on-site inspection process and methods of high-risk
medical devices and the application of inspection results. He would like to understand the risk control
requirements for production of implanted medical devices through site visits. He is also interested in
cardiovascular implants imaging, and orthopedics related technologies.
WANG Ling
Division Director
Medical Device Monitor and Evaluation Division-1, Center for drug reevaluation,
NMPA
Ms. WANG works in monitoring and evaluating adverse events of active medical
devices and IVD reagents. She is engaged in work such as management, technical
specification establishment, subject research, data standardization research,
information system construction and business training. She has a master’s degree.
Delegate Interests:
Ms. WANG’s goal for this visit is to learn about the advanced experience and practice of management and
technology in the U.S. She is interested in learning about the monitoring and evaluation of adverse events on
medical devices. She is also interested in learning about active medical equipment manufacturing, adverse
event monitoring and evaluation, etc. She is interested in technologies for early warning of adverse events
regarding medical devices, monitoring of real-world data security, and rapid evaluation of security.
ZHAO Yifei
Evaluator
Medical Device Monitor and Evaluation Division-2, Center for drug reevaluation,
NMPA
Ms. ZHAO’s current responsibilities include Medical device adverse events monitoring
and post-market evaluation. Ms. ZHAO also worked in clinical pathway of acute coronary
syndrome, phase 3 (an RCT study focused on evaluating the effects of a series of
intervention measures in hospital), data analysis and field study. Ms. ZHAO received a
Master of Science in Public Health School from Peking University Health Science Center.
Delegate Interests:
Ms. ZHAO’s goals for this visit is to gain some knowledge of the post-market supervision system of medical
devices, including how the FDA works, how the FDA cooperates with medical device manufacturing enterprises
and how the FDA cooperates with research institutions.
She is interested in learning how real-world evidence has been used in the practice of post-market monitoring and
regulation. She is also looking to learn how to collect, summarize and make use of the monitoring results of
medical devices’ adverse events. She would like to know to generate risk signals from reported surveillance cases.
She is also interested in knowing how to translate the research results of safety and efficacy of medical devices
into guidelines, regulations or management practices.
She wants to know how the post-market monitoring system of a certain medical device manufacturing enterprise
works. She is interested in active surveillance technologies, as well as the adoption of adverse event terminals
and implementation of patient registry.
DENG Gang
Deputy Director General
Center for Medical Device Evaluation, NMPA
Mr. DENG works in the management of medical device registration, production,
operation, adverse event monitoring and recall. He received a Bachelor of Clinical
Medicine from the China Medical University. He has a Master of Arts degree from
the School of Government Management at Peking University.
Delegate Interests:
Mr. DENG’s goal for this visit is to understand the details of the FDA's pre-market review. He is interested in the
FDA data review, such as the connection of laboratory inspections; the connection of data review and system
inspections. He is interested in the technologies that support the FDA data review, such as the connection of
laboratory inspections; the connection of data review and system inspections.
ZONG Yungang
Deputy Director General
Southern Medicine Economic Research Institute, NMPA
Mr. ZONG’s primary duties include pharmaceutical industry research, pharmaceutical
medical device policy and regulation, and internet drug monitoring. He has a Bachelor
of Engineering from the College of Pharmacy at the China Pharmaceutical University
with a major in Pharmaceutical Chemistry. He has an EMBA from Zhongnan
University of Economics and Law.
Delegate Interests:
Mr. ZONG’s goal is to learn from the advanced measures and experience of U.S. regulators in the supervision
of medical devices. He also hopes to learn from the successful experience of U.S. regulators in safety risk
management of medical device supervision. He is interested in learning about risk prevention and control of
internet sales of medical devices. He would like to learn about the application of Internet regulatory technology.
WEI Xigeng
Deputy Division Director
Medical Device Supervision Division, Beijing Municipal Medical Products
Bureau
Mr. WEI Xigeng is responsible for work such as quality supervision and
management of equipment production, and adverse reactions monitoring. In a
previous position, he served as Deputy Director of the Department of Medical
Device Production Supervision, and was an inspector appointed by the NMPA.
WEI has participated in the inspection of various dosage forms of drugs in
Beijing and China and has a solid theoretical foundation and rich inspection experience. WEI Xigeng has Bachelor
of Science from the School of Pharmacy at Fudan University (formerly School of Pharmacy, Shanghai Medical
University) with a major in pharmaceutical chemistry.
Delegate Interests:
Mr. WEI Xigeng’s goal for the visit is to learn from the advanced measures and experience of U.S. regulators on
medical device supervision and compare the similarities and differences between the two regulatory systems, so
as to clarify ideas for further improving the quality supervision of device production. He is interested in the actual
cases explaining the quality risk prevention and control of medical devices. He is interested in technologies that
support the development of AI in medical devices, as well as recent achievements of cardiac stents and the
application of sterilization technology.
YANG Jingyi
Deputy Division Director
Medical Device Supervision Division, Jiangsu Provincial Medical Products Bureau
Ms. YANG works in medical device production supervision. In a previous role, she
worked in the operation and supervision of medical devices. She graduated from the Law
School of Nanjing University and later obtained a master’s degree in Public
Administration.
Delegate Interests:
Ms. YANG’s goals for this visit is to understand the drug regulatory system in the U.S., focusing on understanding
the institutions, personnel, systems, policies and ideas of medical device supervision, the reasons and orientations
of the changes in regulatory policies in recent years and future regulatory planning, how medical device
supervision links up from pre-market to post-market, as well as the main problems found in current medical device
supervision and solutions or suggestions.
She is interested in medical device supervision. She would like to see and learn about the production and testing
of sterile products manufacturers for medical devices and about the site inspections undergone by medical device
manufacturers. She is interested in technologies for the inspection of sterile products, 3D printing, and EMC.
FU Kai
Deputy Division Director
Medical Device Supervision Division, Shandong Provincial Medical Products Bureau
Mr. FU is responsible for the supervision of active medical devices and market sampling
of medical devices. He has previous experience in the registration of Class II medical
devices, the production license of medical devices, as well as the monitoring and re-
evaluation of adverse events of medical devices. He graduated from Shanghai University
with a master’s degree in Computer Application.
Delegate Interests:
Mr. FU’s goals for this visit is to learn about the background and understanding of GMP for medical devices in
the U.S., as well as the scope and regulation of product traceability. He is also interested in the management of
medical devices (design, conversion, production and inspection). He would like to learn about the production and
inspection of active medical devices. He is interested in EMC, electrical safety and inspection technologies.
ZHANG Feng
Division Director
Medical Device Supervision Division, Guangdong Provincial Medical
Products Bureau
Mr. ZHANG is the director of the Medical Device Supervision Division in
Guangdong Provincial Medical Products Bureau. He graduated from South
China Normal University with a bachelor’s degree.
Delegate Interests:
Mr. ZHANG’s goal for this visit is to gain a comprehensive understanding of the medical device regulatory
system and methods in the U.S. He is particularly interested in learning about the US rules and regulations
governing device manufacturing in China on behalf of US companies. Mr. ZHANG Feng would like to visit
medical device manufacturers and companies such as Johnson & Johnson.