Hundreds of new NMPA regulatory policies, guidelines, standards and announcements were released in 2019. These updates and changes impact the complete product life cycle from new submissions to renewals, as well as postmarket surveillance. For the first time in China, the piloted MAH system allows the separation of the manufacturing entity from the product design entity for domestically made devices. This webinar will teach attendees how manufacturers or inventors can shorten their time to market for new submissions, allow enough lead time for renewal and when to file for modifications to avoid penalties.
The session will provide an overview of the key NMPA changes and their implications on manufacturers. Topics include:
- Standards & Guidelines
- Clinical Pathways: Overseas Clinical Data Acceptance & Piloted Real World Data
- MAH, UDI & eRPS
- SaMD & AI
- QMS (AE, Recall & Overseas Inspection)
Grace Fu Palma, CEO of China Med Device, LLC
Grace brings 20+ years of industry experience to the medical device industry. She has extensive management experience in marketing, business development, partnerships, and international commercialization from large multinational corporations (Hewlett Packard Medical Products Group, Phillips Healthcare) to start-ups (Teratech Corp). As the founder of the Chinese American Heart Association in 2005, she built the 500-member leading cardiovascular clinicians and scientists’ society with Chinese origins. The combination of cross-cultural mentality and deep Sino-U.S. medtech knowledge and professional experience in China and the United States has enabled CMD to help more than 50 medtech companies with their China entry and growth since its inception. Grace is originally from Beijing, China and graduated with a Bachelor’s degree from Beijing University and an MBA from Yale University.
Jason Zhang, MD, Director CRO, China Med Device, LLC
Jason Zhang worked as the clinical affairs manager at Philips Healthcare and clinical data manager at Merck & Co. Jason has a proven track record in the entire spectrum of clinical trials, from site selection to the preparation of PRT, CIB, CRF, ICF, IRB, and PRT discussion meeting, clinical data monitoring, management, statistical analysis, clinical research, evaluation and reporting and final site closing. Product examples include, but not limited to: NanoFuse for bone trauma, hemoconcentrator, focused ultrasound for contouring, precision infusion project, polysaccharide hemostatic material project, MR-HIFU (MR guided High Intensity Focused Ultrasound) in Uterine Fibroid treatment and MRI imaging systems.
Jason received his MD from North China Medical College (NCMC) and master in Pathology from Peking Union Medical College (PUMC) with specialties in Clinical Medicine, Clinical Pharmacology, Pharmacology and Medical Statistics.