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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 2021
Hundreds of new regulations in the forms of policies, guidelines, standards and announcements are released in in 2020. These updates and changes have impacted the complete product life cycle from new submissions, renewals to post market 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. With the sweeping changes, how can manufacturers or inventors be proactively 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.
Audience Learning Level
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Who Should Attend
Grace Fu Palma,
CEO, China Med Device, LLC
Grace, a seasoned medtech executive, specializes in helping U.S. medical device companies to accelerate their regulation & commercialization in China. With 20+ years of experience driving product strategy, regulatory approval, business and channels partnership and market development for both large multinationals and startup companies, she held a variety of marketing, operations and strategic development management positions. Bi-lingual, bi-cultural and deep Sino-U.S. medtech connections and practical knowledge and experience. Founder of Chinese American Heart Association (CnAHA) in 2005.