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Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is an On-demand recording from February 2022.
The China National Medical Products Association (NMPA) introduced a series of significant changes to medical device, IVD, companion diagnostic, and combination products regulations in 2011. Dozens of new regulations and major updates in the forms of policies, guidelines, standards, and announcements were released in 2021 with the implementation of decree Order 739, “Regulation on the Supervision and Administration of Medical Devices”.
In a significant progression, Chinese medical device regulators have begun to recognize the self-test report [JM1] from manufacturers and developed guidelines on the requirements and qualifications for self-test reports.
China has also published adjustments to the Good Clinical Practice (GCP) framework, including guidelines for Clinical Evaluation Reports (CER), establishing equivalence, and determining when to do clinical trials. The e-filing catalog has also added a section requirement on Good Manufacturing Practice (GMP). These updates and changes have impacted the complete product life cycle including new submissions, renewals and postmarket surveillance.
Sign up for this live webcast and learn how these updates and changes affect your work and what to expect from the China NMPA in the year ahead.
Upon completion of this program, you will:
Grace Fu Palma brings 20+ years of MedTech and diagnostic industry experience. She is the CEO of China Med Device with offices in Beijing, Hainan and Boston, providing turnkey solutions for western medical device/IVD/CDx products companies to enter China with NMPA (CFDA) regulatory and clinical affairs (RA, QA, CER, RWD, CRO etc.) services. The company has processed 1,000+ NMPA certificates and accelerated 250+ Chinese and western companies’ success. A seasoned bilingual and bicultural MedTech executive, she has held a variety of marketing, operational and strategic development management positions at both large multinationals and startup companies. She specializes in China NMPA (CFDA) regulatory (RA/QA/CRO/CER) and commercialization services. In addition, she founded the Chinese American Heart Association (500+ cardiovascular clinical professionals) in 2005. She is a regular speaker at key national and local MedTech meetings and a frequent contributing writer to multiple regulatory journals. Grace grew up in Beijing, China and received a BA degree from Peking University, China, and an MBA from Yale University in New Haven, CT.