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2020 NMPA (CFDA) Key Updates and Look Ahead on 2021

1.0
RAC Credits
Thursday, 25 February 2021 (10:30 AM) - Thursday, 25 February 2021 (11:30 AM) Eastern Time (US & Canada)

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.

Topics include:

  • Standards & Guidelines
  • Clinical Pathways: Overseas Clinical Data Acceptance & Piloted Real-World Data
  • MAH, UDI & eRPS
  • SaMD & AI
  • QMS (AE, Recall & Overseas Inspection)


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.


Learning Objectives

  • Upon the conclusion of the program, you will be able to:
  • Understand the key regulatory and clinical requirement changes that took place in 2019 and implications.  
  • Explain the top five strategic factors to consider in submission that will impact approval time, downstream sales and post market compliance.
  • Discuss the implications and actions needed to take place as a result of the 300 technical standards updates in new submission, modification and renewals.


Who Should Attend

  • Clinical affairs professionals
  • Managers in the life sciences industry
  • Regulatory affairs professionals
  • Quality affairs professionals
  • Medical affairs professionals
  • R&D managers
  • Compliance managers
  • Operations managers
  • Marketing and business executives
  • Chief financial and commercial managers


Speaker

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.