New update on China NMPA Regulation and Registration for Medical Devices with Case Studies
You will get a deep understanding of the up-to-date China NMPA regulatory policies
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.
- 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.
Dr. Chao Xu, Co-Founder, J MedTec Limited Shanghai
"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"
Participants, Fall 2021