Opportunities and challenges for the localization of international IVD brands in China

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Opportunities and challenges for the localization of international IVD brands in China

In recent years, China has become an increasingly competitive market for international companies. Its huge consumer groups and diverse demands have formed a broad market development prospect, which is greatly attractive to many international companies.

According to 2019 data from the Ministry of Commerce, about 490 of the global top 500 companies have invested in China, accounting for about 98% of the total. The Chinese market has important strategic significance for international brands to seize the global market and enhance brand image.

Despite the huge potential of the Chinese market, its complex market structure, policies and regulations and technical safety supervision often make some overseas in vitro diagnostic companies passive. This webinar will conduct a comprehensive analysis and interpretation on topics such as Chinese market size, market access and product registration, laws and regulations, and technical safety supervision of Chinese IVD industry, helping overseas IVD brands to gain comprehensive insight into Chinese IVD industry market, so as to achieve localized development in such an important global market.

Clinical Laboratory Growth in China: From Clinical Work to Science Development in Nanfang hospital

Speakers profile

Prof Lei Zheng
Dean of the Department of Laboratory
Medicine Nanfang Hospital, Southern Medical University

Lei Zheng is the professor at Southern Medical University (SMU). He serves as Dean of the Department of Laboratory Medicine, Nanfang Hospital, Southern Medical University. His scientific interests focus on interdisciplinary research for disease diagnosis. He has published over 250 papers which have been cited over 9,000 times, with an h-index of 47. He is the vice president of the Chinese Society for Extracellular Vesicles (CSEV) and used to serve as the Executive Chair of the International Society for
Extracellular Vesicles (ISEV) education committee (2020-2022). He received The National Science Fund for Distinguished Young Scholars in 2020 and the Chinese Experimental Medicine Outstanding Youth Award in 2020.

In this report, Dr. Zheng will take the Department of Laboratory Medicine in Nanfang Hospital he led as an example, to introduce how to better develop clinical labs in Chinese medical institutions. His report will focus on several aspects, including medical laboratory quality control and management, undergraduate and graduate education, scientific project development, public campaign, etc.

Speaker: Prof Lei Zheng

Overview of China IVD Industry and Its Future Development

Speakers profile

Karen DAI
International Director, CACLP

Speaker: Karen DAI

An overview to IVD Registration in China

Speakers profile

Dr Zhen Liu
Vice General Manager
Beijing Zhongguancun Shuimu Medical Technology Co., Ltd.

The presentation first introduces Regulation structure in China. The regulation structure consists of four parts: Law, Order, Decree, and Normative documents. Law refers to China office and State office documents. Order mainly refers to Order 739. Normative documents refer to Notice guidance and GCP. Under Order 739, contains four contents, namely GRP, GCP, GMP and GSP. Secondly the presentation elaborates Risk Classification of IVD products. Medical devices are classified three Categories according to risk.

Class I: low risk, Class II, medium risk, Class III, high risk. Class I shall be subject to product recordation administration, Class II and Class III I shall be subject to product registration administration. Domestic Class I products shall be applied to the municipal Drug Administration. Domestic Class II products shall be applied to the provincial Drug Administration. Domestic Class III products shall be applied to Drug Administration under the state council. For Imported products, No matter Class 1, class 2, or class 3, shall be applied to Drug Administration under the state council. Finally, Registration path for IVDs is analyzed and elaborated, including registration stage and production licensing process.

Speaker: Dr Zhen Liu

IVD Regulatory Pathway in China

Speakers profile

Qi Li
Head of Quality and Regulatory Affairs
Beckman Coulter, China

Ms. Qi Li has 27 years of experience in quality and regulatory affairs in Pharmaceutical, Medical Device and IVD industry. She has served successively as the different leadership roles in Regulatory and Quality Department in China, Asia Pacific and R&D centers in Roche Pharma, AstraZeneca, Covidien and Medtronic, etc. She also served as Vice Chair of the IVD Regulatory Working Group in APACMed (an AsiaPacific based industrial association. Her report is about the introduction of China regulators and the registration pathway of IVD products.

Speaker: Qi Li

Roche Diagnostics in China’s new development pattern

Speakers profile

Luca Xu
Head of Corporate Affairs & Market Access
Roche Diagnostics (Shanghai) Ltd.

Mr. Xu leads the Company’s strategic partnerships, corporate influence, macro & industry policies, government affairs, corporate social responsibility, market access, health economics research, etc. Mr. Xu holds a master’s degree in health service management and a bachelor’s degree in clinical medicine. Prior to joining Roche Diagnostics in 2012, he worked for the Ministry of Health, Plan International, Powell Tate and P&G, well-experienced in government affairs, strategic planning, market access, CSR, crisis management, etc.

Speaker: Luca Xu
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