Starting January 1, 2026, NMPA will further expand its pre-submission technical consultation program for medical device registration. In addition to the National Center, three regional branches—Beijing-Tianjin-Hebei, Central China, and Southwest China—will provide structured pre-acceptance technical consultations, joining the already established Yangtze River Delta and Greater Bay Area centers. This move is designed to improve regulatory efficiency, consistency, and predictability for manufacturers, including overseas companies entering the Chinese market.
Who Organizes the Program
The program is led by the of NMPA Center for Medical Device Evaluation (CMDE), so called National Center, which oversees policy consistency and implementation. Five regional sub-centers operate under CMDE guidance and handle consultations within their respective territories.
Responsible Territories
- National Center: On-site consultation applications from across China, and email consultation applications from regions outside the jurisdiction of the five branch centers.
- Yangtze River Delta Branch Center: Shanghai, Jiangsu, Zhejiang, and Anhui provinces.
- Greater Bay Area Branch Center: Guangdong province, Hong Kong, and Macau.
- Beijing-Tianjin-Hebei Center: Beijing, Tianjin, Hebei, and Shandong provinces.
- Central China Center: Hubei, Hunan, Henan, and Jiangxi provinces.
- Southwest Center: Chongqing, Yunnan, Guizhou, Sichuan provinces, and the Tibet Autonomous Region.
Who Can Apply (Overseas Perspective)
For overseas manufacturers, the key eligible applicant is:
- The China-based legal entity that holds equity in the overseas manufacturer, such as a wholly foreign-owned enterprise (WFOE) or joint venture established in China, acting as the registration applicant for Class III medical devices.
This makes the program particularly relevant for foreign companies planning:
- First-time Class III device registration in China
- Innovative device pathways
- Clarification of technical, clinical, or regulatory expectations before formal submission
Scope of Consultation
Pre-submission consultations may cover:
- Active and non-active medical devices
- In vitro diagnostic (IVD) devices
- Innovative medical device review pathways
- Key technical and clinical evaluation questions prior to dossier submission
Each consultation allows up to five clearly defined questions, focused strictly on the responsibilities of the relevant review department.
Consultation Format
Two formats are available:
- On-site consultations (some centers may offer video conferencing when appropriate)
- Email-based consultations, which are especially practical for overseas-linked teams
The National Center typically responds to email inquiries within five working days, while regional sub-centers respond within 10 working days.
Regional Allocation Rules
From 2026 onward:
- On-site consultations may be booked either with the National Center or the regional sub-center where the applicant entity is registered
- Cross-region selection is not permitted
- Email consultations must be sent only to the appropriate regional sub-center, not to National Center mailboxes
This regionalization reduces bottlenecks and shortens communication cycles.
Practical Considerations for Overseas Manufacturers
- Applications must strictly follow naming conventions, document formats (Word/Excel only), and submission time windows
- Incomplete or incorrectly formatted submissions will be rejected without review
- Each company may submit only one on-site consultation request per week
- Missed appointments may lead to temporary suspension of on-site consultation privileges
Why This Matters
For overseas manufacturers, this expanded consultation mechanism provides:
- Earlier regulatory clarity
- Reduced risk of technical deficiencies at formal submission
- Better alignment with China-specific clinical and technical expectations
- Improved planning for timelines and resource allocation
The expanded pre-submission consultation framework reflects China’s continued effort to increase transparency and regulatory efficiency, making early engagement with NMPA reviewers a practical and valuable step for foreign medical device companies targeting the Chinese market.