Hundreds of new regulations in the forms of policies, guidelines, standards and announcements are released in in 2019. These updates and changes have impacts not only on new submissions, but also approved and renewal products. 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. The webinar will teach attendees how can manufacturers or inventors be proactively prepared to shorten their time to market for new submissions and allow enough lead time for renewal as well as to know when to file for modifications to avoid penalties.
The session will provide an overview of the key changes and their implications to manufacturers. Areas covered but not limited to:
- Standards & Guidelines
- Clinical pathways: Overseas Clinical Data Acceptance, piloted real world data
- MAH, UDI, eRPS
- SaMD and AI
- QMS (AE, Recall, Overseas Inspection)
Grace Fu Palma, CEO of China Med Device, LLC
Grace brings 20+ years of industry experience to the medical device industry. She has extensive management experience in marketing, business development, partnerships, and international commercialization from large multinational corporations (Hewlett Packard Medical Products Group, Phillips Healthcare) to start-ups (Teratech Corp). As the founder of the Chinese American Heart Association in 2005, she built the 500-member leading cardiovascular clinicians and scientists’ society with Chinese origins. The combination of cross-cultural mentality and deep Sino-U.S. medtech knowledge and professional experience in China and the United States has enabled CMD to help more than 50 medtech companies with their China entry and growth since its inception. Grace is originally from Beijing, China and graduated with a Bachelor’s degree from Beijing University and an MBA from Yale University.