Latest Medical Device Postmarket Surveillance Requirements from China’s NMPA and the U.S. FDA – Webinar Recording/Transcript
China’s National Medical Products Administration (NMPA) has introduced hundreds of new regulations that affect the complete product life cycle of medical devices, from new submissions to postmarket surveillance (PMS).
Join us and get up to speed on the regulatory reform in China that impacts the medical device and in vitro diagnostic (IVD) industry and get answers to key questions:
- What are the regulations and requirements for FDA and NMPA inspections? How can you be prepared for it?
- How do you leverage a legal agent in China to increase your compliance by understanding their roles and responsibilities?
- How can you leverage the piloted marketing authorization holder (MAH) system that allows the separation of the manufacturing entity from the product design entity for domestically made devices?
- What are the FDA regulations for importers, U.S. agents and subsidiaries?
- Learn about the latest requirements and regulations for PMS and QMS in the NMPA and FDA
- Discover how to assess and determine the new piloted marketing authorization holder (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 Presenters
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 postmarket), 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 postmarket surveillance to accommodate the difference between the East and West.
Jason Liang, Quality Assurance Director of China Med Device, has more than 15 years of QA/RA experience in medical device/IVD. He has held QA and RA management positions in several international corporations including Philips, Intertek, and TÜV Rheinland. Jason is veteran auditor of medical device/IVD QMS for both international and domestic manufacturers in China. He is an expert on ISO 13485, QSR 820, China cGMP and understands the QMS dynamics between China, US, and EU. He has performed audits on a wide range of manufacturers in medical devices and IVDs (active, non-active), such as GE, Shimadzu, Fukuda, Panasonic, and many China domestic manufacturers.
With more than 18 years of experience in medical device quality assurance, Dan Goldstein is an Associate Director of Quality Assurance at MCRA. His primary focus is on quality system requirements for bringing new devices to market and on keeping experienced manufacturers in compliance with FDA and Notified Bodies. Dan provides MCRA clients with gap assessments, mock FDA inspections, Form 483 remediations, manufacturing transfers, design history files, technical documentation and MDD-to-MDR updates.
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
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Nov. 12, 2020