China’s NMPA (CFDA) – Webinar Recording/Transcript
China’s NMPA (CFDA): Latest Regulatory Updates with QMS-PMS Focus
The National Medical Products Administration (NMPA) — formally known as the China Food and Drug Administration — has introduced hundreds of new regulations that affect the complete product life cycle of medical devices, from new submissions to product changes.
How can manufacturers, inventors, and investors be prepared to shorten their time to market for new submissions, allow enough lead time for renewal as well as to know when to file for modifications to avoid penalties?
Get up to speed on the regulatory reform in China that impacts medical device and in vitro diagnostic (IVD) industry and get answers to key questions:
- What are the new post-market surveillance (PMS) regulations and implications in adverse events and recalls reporting? Are your sales channels or distributors meeting the China good supply practices (GSP) and distribution requirements?
- For overseas manufacturers, what the regulations and requirements for overseas inspections? How can you be prepared for it?
- If you have suppliers in China, what are the China good manufacturing practices (GMP) requirements? What are the common issues?
- For the first time in China, the piloted Marketing Authorization Holder (MAH) system allows the separation of the manufacturing entity from the product design entity for domestically made devices, can you leverage it?
- Determine how to leverage a legal agent in China to increase your compliance by understanding their roles and responsibilities
- Discover how to assess and determine the new piloted MAH system by understanding its MAH qualification requirements and responsibilities
- Familiarize yourself with how to leverage your overseas QMS for your China operations by understanding China GMP regulations and Chinese culture differences
- Find out how to comply with required adverse events (AE) and serious adverse events (SAE) reports, including how to differentiate between AE and SAE and when to report
Join us for clarity on China’s regulatory reforms impacting the medical device and IVD industry.
Meet Your Presenter:
Grace Fu Palma, CEO of China Med Device, LLC
Grace Fu Palma, CEO of China Med Device, LLC, a seasoned medtech executive who specializes in accelerating U.S. medical device companies’ entry and growth in China with regulatory and commercialization services. With 20+ years of experience driving global product strategy, commercialization, partnerships, and China operations for both large multinationals and startup companies, she held a variety of management positions in marketing and operations at multinationals and start-ups. She founded China Med Device, LLC (CMD) in 2011. CMD (www.ChinaMedDevice.com) helps medical devices & IVD companies with turnkey commercialization services from market assessment, regulatory (premarket approval, legal representation, clinical evaluation, clinical trial, and post-market), to distribution management in China. With an office in Beijing and an office in Boston, CMD provides 24/7 CFDA regulatory consultation services from pre-market submission to post-market surveillance to accommodate the difference between the East and West. She grew up in Beijing, China and received a BA degree from Peking University, China, and an MBA from Yale University in New Haven, CT.
Who Will Benefit:
- All medical device and IVD companies, inside or outside of China
- Start-ups who want to go to China
- Investors and equity firms
- Inspection and audit
- Regulatory affairs professionals
- Clinical affairs professional
- Product managers
- R&D managers
- Marketing managers