China Med Device
•Founder and CEO of China Med Device, LLC (www.ChinaMedDevice.com) with offices in Beijing and Boston providing regulatory, clinical and commericial turnkey solutions for medical device/IVD/CDx/Combination products to enter China. Our accomplishments: 1,000+ CFDA certificates, 250+ companies’ success.
• As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to set up local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, PTR, clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection etc).
•Seasoned bilingual and bicultural MedTech executive, specializes in China NMPA (formerly CFDA) regulatory and commercialization services.
•20+ years of experience driving global business strategy, commercialization, partnerships, and China operations for both large multinationals and startup companies.
•Regulator speaker and contributor at key national and local MedTech meetings, a frequent contribute writer to multiple journals, FDA News, RAPS Forum, Medtech News etc.
• Founded Chinese American Heart Association in 2005 with 500+ cardiovascular clinicians in US and China.
•Grew up in Beijing, China and received a BA degree from Peking University, China, and an MBA from Yale University in New Haven, CT.
Monday, September 23
4:00 PM – 5:30 PM