China In Vitro Diagnostic (IVD) Webinar for U.S. Exporters
12/06/2023
11:00 AM to 12:10 PM
(GMT-04:00) Eastern Time (US and Canada)
About

(Date and Time: 11:00 a.m., December 6, EST/8:00 a.m., December 6, Pacific Time/ 12:00 midnight., December 7, Beijing Time)

China's IVD market maintains strong momentum driven by the country's large population, aging society, and people's increasing healthcare expenditure. Imported products remain robust in upstream and high-end markets. From 2019 to 2022, U.S. exports to China have reported steadfast growth in major categories, such like blood products (HS3002), reagents (HS3822), medical and surgical devices (HS9018) and analytical devices (HS9027).

This webinar will provide you with valuable insights into the latest trends, opportunities, and challenges in this dynamic industry. We've assembled a panel of insiders who will share their knowledge and expertise on various aspects. You'll gain a deep understanding of the regulatory landscape and market entry strategies.

Agenda

  • Welcome Remarks, U.S. Embassy Beijing (5')
  • 'Perspectives on the IVD Market in China' by Mr. Jia Luo with China Association of In-Vitro Diagnostics (15')
  • 'NMPA Regulatory Requirements and Registration Pathway' by Grace Fu,  Founder and CEO of China Med Device, LLC (10')
  • ‘Eight Tips to Succeed in China IVD Business' by Santiago Ramos Bordajandi,Managing Director & Senior Consultant, AI&C Limited (10')
  • 'IP Protection in China', IP Attaché Conrad Wong, U.S. Patent and Trademark Office China (10')
  • CACLP 2024 Introduction, by Ms. Karen Dai, Executive General Secretary of China IVD association (10')
  • Q&A (10 minutes)
(Please click the registration button, and sign in with your existing InEvent account or create a new account for registration. If you have any questions, please contact Catherine.Le@trade.gov; Ming.Yang@trade.gov) 
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Speakers
Speaker

Jade Sims, U.S. Embassy, Beijing

Jade Sims, Commercial Officer
Jade Sims arrived in Beijing, China to begin her first tour as a Commercial Officer in August of 2022.
Her portfolio covers several industries, including advising the China Healthcare team. Prior to her work with U.S. Commercial Service, Ms. Sims was Assistant Director of International Trade Programs at Michigan State University’s International Business Center, where she provided trade counseling, training, and market research to U.S. exporters. She also taught international business and developed and led study abroad and internship programs on four continents.
Prior to her work at MSU, Ms. Sims worked in the automotive industry and served as a small business development volunteer with the Peace Corps. She holds an MBA Thunderbird School of Global Management and a BS in Business and Spanish from Alma College.

Jia Luo, China Association of In-Vitro Diagnostics

Jia Luo

Director of Product Planning, Vice Chairman Unit of China Association of In-Vitro Diagnostics

BA of Biomedical Engineering From Zhejiang University, China.

PhD of Biochemistry and MSc of Molecular Neurobiology from University of Bristol, UK.

Postdoctoral Fellow at the Sheffield Institute of Translational Neuroscience, UK.

 Served as chief engineer, R&D manager and R&D director in R&D Department of Zyibo Inc.

Current place is Product Director in Planning and Development Department of Zybio Inc.

 He has ten years of experience in China's IVD industry and has been engaged in diagnostic-related R&D and management work. The areas involved include diagnostic raw materials, rapid test, clinical chemistry, immunoassay and other fields. Now he focuses on scanning and mining clinical and market requirements, planning new products and product portfolios according to valuable requirements, and organizing their industrial transformation and introduction to the market. He is familiar with the current situation of China's IVD market and is full of expectations and confidence for the future.

Grace Fu, Founder and CEO of China Med Device, LLC

Grace Fu is the founder and CEO of China Med Device, LLC (www.ChinaMedDevice.com) with offices in Beijing and Boston providing one-stop solutions for western medical device/IVD companies to enter China with regulatory, clinical affairs and commercialization services.

She is a seasoned bilingual and bicultural MedTech executive, specializes in China NMPA (formerly CFDA) regulatory and commercialization services, with 20+ years of experience driving global and China business strategy, regulatory and clinical affairs, commercialization, partnerships, for both large multinationals and startup companies. She has been a regulator speaker on China regulatory, clinical affairs and market access subjects at key national and local MedTech meetings,  and contributing to multiple industry and regulatory journals, Medtech News, etc. Some of her China NMPA presentations and writings can be viewed at https://chinameddevice.com/resources3/,  a China regulatory and clinical affairs intelligence portal for Western medical device manufacturers.

She also founded Chinese American Heart Association (CnAHA) in 2005, a leading Chinese cardiovascular clinicians society with members and presence in both China and US.

Grace grew up in Beijing, China and received a BA/BS joint degree from Peking University, China, and an MBA from Yale University in New Haven, CT.

Santiago Ramos Bordajandi , Al&C Limited

Santiago Ramos Bordajandi

Managing Director & Senior Consultant, Al&C Limited

Santiago brings 25+ years of broad International Corporate experience, Independent Consultancy & Advisory practice.

Over the years, Santiago has successfully developed business in America, Africa, EU and Asia undertaking roles of increasing seniority in Finance, General Management and ultimately as a C-Level Senior Executive and an Advisor/Consultant.

Leads projects in:

• Corporate Strategy

• International Expansion & go-to-market

• Commercial Operations

• Rapid growth

• Negotiation & Complex Environments

• Group and Individual Executive Mentoring

• Teams Management

• Multicultural integration & communication

• China, Japan & Korea expertise (GTMS, Strategy, Business Plan, Management,…)

Company Website: www.aiandclimited.com

Conrad W. Wong, Senior Attorney, USPTO

Conrad Wong is a Senior Attorney with the China Team in the Office of Policy and International Affairs at the headquarters of the Patent and Trademark Office (PTO) in Alexandria, Virginia.  He specializes in American and Chinese intellectual property law and enforcement matters, formulates and promotes U.S. intellectual property policy, and assists rights holders in registering and protecting their intellectual property assets.

From 2007 to 2012 and again from 2019 to 2022, he was resident in China, representing the PTO as the Intellectual Property Officer with the United States Consulate General in Guangzhou.  Concurrent with his assignment to the China Team at PTO Alexandria, he continues to supervise remotely the activities and local staff of PTO Guangzhou.  He is responsible for American intellectual property issues in southern and southwestern China as well as the Special Administrative Regions of Hong Kong and Macao.

He has 30 years of experience in intellectual property matters, representing the United States Government and the private sector.  In 1993, he joined the PTO as a Trademark Examiner, became a Senior Attorney, and then joined the Office of Policy and International Affairs.  Prior experience includes clerking for a Maryland state trial judge, and litigation practice in insurance-defense matters in Washington, D.C.  He has served as a government-relations representative for an automotive trade association.

He is a graduate of The Johns Hopkins University and Georgetown University Law Center.  Fluent in Cantonese, he is admitted to practice law in the District of Columbia and the State of Maryland.

Karen Dai, General Manager of CACLP

Karen Dai

General Manager, CACLP

Karen Dai is the Executive General Secretary of China Association of In-Vitro Diagnostics (www.caivd-org.cn) and the General Manager of CACLP (www.caclp.com).

Ms Dai has more than 20 years’ experience in trade fair industry and has successfully launched some key international shows in China in different industries. After joining in CAIVD and CACLP in 2020, she has been dedicated to developing the international network for global IVD companies together with the team. The mission of CAIVD and CACLP is to introduce the China market to overseas companies, and help Chinese companies connect with the global market!