Cindy Hu has more than 20 years’ experience in the medical device industry in China, including regulatory, quality and clinical research in various therapeutic areas. Cindy and her team provide consultation to numerous global medical device manufacturers on China’s National Medical Products Administration (NMPA) regulatory affairs, including creating strategic plans, registration and filing, clinical evaluations and post-market support under the new regulations. Prior to working at NAMSA, Cindy worked for Stryker China, GE Healthcare China and Fenwal Inc. with leadership roles in regulatory affairs and quality Assurance. She received her Bachelor of Science degree in Electrical-Mechanical Control and Detection from Beijing University of Aeronautics and Astronautics.
- Developing and executing regulatory strategies for China NMPA submissions
- Developing clinical strategies for clinical studies in China and globally, including identifying clinical pathways in China
- Leading numerous registration submissions of new medical device products (Class II and III), including attending panel meetings, communicating with NMPA reviewers and working with the local testing lab on type testing
- Providing regulatory consultancy as the legal agent in China for global manufacturers
- Performing supplier audits on quality system in compliance with ISO 13485, China Good Manufacturing Practice (GMP) and U.S. Food and Drug Administration (FDA) part 820
- Performing due diligence on quality/regulatory compliance on behalf of manufacturers