Webcast: China NMPA Medical Device Latest & Most Important Policy: Key Highlights of Order 739

1.0
RAC Credits
Wednesday, 02 June 2021 (10:30 AM) - Wednesday, 02 June 2021 (11:30 AM) Eastern Time (US & Canada)

China NMPA overarching policy “Regulation on the Supervision and Administration of Medical Devices”, or Order 739, will be effective on June 1st, 2021. This new policy from China State Council has 8 chapters and 107 articles covering the complete product life cycle in an effort to create a more efficient and less burdensome approval process. For overseas medical device/IVD companies, it means faster China market access. In this webcast, we will review the key highlights of this new policy and the implications for overseas companies in premarket submission clinical and technical requirements, innovation focus, MAH and post market changes.

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

  • Understand the key content of Order 736 covering the whole product lifecycle
  • Grasp the most significant implications for overseas manufacturers including accepting self-test or 3rd party test reports
  • Find more versatile clinical evidence to support clinical evaluation and fast approval pathways for urgent use/innovation
  • Avoid the significantly increased post market monitoring and penalties

Who Should Attend?

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

Speakers

Grace Fu Palma, MBA, CEO, China Med Device LLC

Grace Fu Palma has more than 20 years of medical technology and diagnostic industry experience. She is the CEO of China Med Device, providing turnkey solutions for western medical device/IVD/CDx products companies entering China. The company has processed more than 1,000 China National Medical Products Administration (NMPA) certificates, and accelerated more than 250 companies’ success. A seasoned bilingual and bicultural MedTech executive, Fu Palma has held a variety of marketing, operational and strategic development management positions at both large multinationals and startup companies. She specializes in China NMPA and commercialization services. She grew up in Beijing, and has a bachelor’s degree from Peking University, China, and an MBA from Yale University.


Yan Sheng, PhD, Project Manager, China Med Device LLC

Yan Sheng grew up in China and has years of experience working in the life science industry in both the US and China, and has more than eight years of experience as a project manager at a CRO. She has experience with drug development companies in both the US and China such as Alfa Chemistry Inc. in the US, and Hangzhou Huadong Medicine Group Co. Ltd. in China. Sheng has six years of experience in the academic field working with cutting edge technologies in both chemistry and microbiology, and has extensive research expertise in natural products chemistry, molecular biology and microbiology, genetic manipulation, protein expression and purification, and in vitro enzymatic reactions. Sheng has been published in a number of academic journals and has a PhD in pharmaceutical sciences.