Medical Device

China Localization Models

China Localization General Process

Localization Mode Self-Build Acquisition MAH
Legal entity in China
Factory construction
Design transformation To be assessed
Sample trial production
NMPA registration-related research To be assessed
NMPA on-site QMS inspection
NMPA registration approval
Production license

Domestic Medical Device NMPA Registration Process

China NMPA On-Site QMS Inspection for Domestic Medical Device Registration

Step 1Submit NMPA registration and receive acceptance
Step 2Submit request for inspection to local NMPA
Step 3Local NMPA perform onsite inspection
Three Possible Results
(1) Pass (2) Pass with Rectification (3) Not Pass
Report to NMPA Submit rectification report within 1 month Re-inspection after at least 3 months

Key documents required for domestic registration submission

  1. Product risk analysis information.
  2. Product technical requirements.
  3. Product type testing reports.
  4. Clinical evaluation information.
  5. Product specifications and sample labels.
  6. Product development, production-related quality management system documents.
  7. Other information to prove product safety and effectiveness.
Notes: The domestic registration can leverage the previous registration dossier used for the imported registration, which may shorten the timeline for submission dossier preparation and NMPA technical review.

China Localization Webinar Videos

BradyKnows Service

China localization strategy
China NMPA registration
Medical device life-cycle regulatory compliance
Quality management system establishment and gap analysis
Quality management system mock audit
Medical device production license application


China CER Feasibility Self-Evaluation