Course objective and outcome

Chinese market becomes more and more important for medical device manufacturers due to its large volume. The NMPA registration process is very time and cost consuming. Also, China NMPA is updating the regulations very rapidly recently. 

This course aims to provide the participants a deep understanding of the up-to-date NMPA regulatory policies and practical solutions to the problems of frequent occurrence during Chinese market entry.

Content

• NMPA organization reform and regulation system
• Important concepts for NMPA registration
• Product registration III
• “Made in China” Strategy: Registering a domestic device
• Vigilance and inspection
• Registration renewal and change
• Green channel for innovative device and prioritized device

Who should attend

This course is suitable for not only RA and clinical professionals who manage the product approval work, but also international marketing and C-level directors who are interested in Chinese marketing strategy.

Trainer

Dr. Chao Xu, Director of International Business, Keuro Solutions

What previous participants said (Fall 2021)

"Chao was great at presenting the updates to the chinese, as well as mentioning the nuances of the requirements and how these are interpreted"

"The course leader is very competent and understand Chinese regulation and mentality"

"I liked the capability of the course leader and the content of the course"

"The Instructor was quite experienced and could bring theory and practice together"

"Great speaker with deep knowledge in the subject"