Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
China’s overhaul of medical device and IVD regulations could mean huge benefits. Manufacturers have additional options for fast-track approvals and more flexible testing / clinical-evaluation pathway requirements. Is your company positioned to benefit from a faster and less costly market entry?
Medical devices and IVD manufacturers are facing a vastly different regulatory landscape in China today. China Med Device publishes the 2026 China NMPA Blue Book, the 8th edition to capture the key regulations updates and changes for the entire product life cycle in 2025. This is our 2025 working documents used to help our clients to accelerate their China market entry. Now we are excited to share with our industry colleagues to keep up to date with the constant changes in China’s medical device regulatory reform as we did throughout 2025 across technical, clinical and general updates.
Sign up to get a complimentary copy today
This 160+ page guide outlines regulatory changes to Product Registration, Clinical Evaluation, Post Market Compliance, Quality Management System and Manufacturing requirements.
For a 15 minute complimentary consultation on the impacts of these changes to your business, please indicate it when you submit your survey.
“The China NMPA Blue Book will help foreign medical device and diagnostic companies to overcome the barriers and to be kept informed of the Chinese regulatory system due to language and culture differences. It will be a valuable tool for overseas companies to enter China.”
— Mr Gong Zhi Jun, Director Administration Institute of Executive Development NMPA