Get the latest on new policy updates and guidance for the clinical evaluation of medical devices.
China’s regulator, NMPA, continues to roll out new and updated guidance documents for medical devices and IVDs. This session will review key regulatory and clinical developments so far in 2024 and look ahead to the remainder of the year. Topics will include clinical evaluation, preferential policies for localized products, and post-market surveillance.
Key Topics
- Overview of China’s regulatory landscape: key regulations, guidelines, and standards.
- Pathways for China clinical evaluation: decision tree, overseas clinical data, clinical trials, and CER.
- Special policies for the use of non-approved devices within the Greater Bay Area and Hainan.
- “Made-in-China” measures to shorten regulatory approval timelines.
- New requirements for Quality Management Systems (QMS) and post-market surveillance.
Meet the Speaker
Grace Fu Palma, MBA
Founder and Principal, China Med Device, LLC
- 20+ years of experience driving global strategy, commercialization, partnerships, and cross border operations for both large multinationals and startup companies.
- Led and managed cross-border teams developed regulatory and clinical strategies and execution of the associated submission and clinical evidence a couple of hundred companies.
- Established and led team to provide practical guidance and execution in China MAH, GMP, overseas inspections, and post market compliance,
- Regulator speaker at key national and local Medtech meetings (RAPS, AdvaMed, FDAnews etc) and writer for multiple journals on NMPA (CFDA) regulatory and clinical affairs.
- Grew up in Beijing, China, received Joint BA/BS-Peking University, China, and an MBA-Yale University, USA.
- Founder of Chinese American Heart Association in 2005 (www.CnAHA.org) with 500+ cardiovascular clinicians and researchers with Chinese origin.
Registration Pricing
This webinar is free for AdvaMed members. Click here to check if your company is an AdvaMed member.
- AdvaMed Members: $0.00
- AdvaMed Accel Members: $0.00
- Non-Members: $150.00
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