NMPA Registration

All companies planning to sell or distribute a medical device or IVD in China must register their product with the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration or CFDA. The NMPA reviews all device applications, and has strict requirements for submission documentation, testing, and clinical data. Medical devices are classified based on NMPA Order 15 and the NMPA classification database. Class I devices need to submit applications with a technical dossier including detailed technical information, clinical data, and quality documentation to the NMPA. For Class II and III devices an additional on-the-spot testing in accredited laboratories in China is required.

STEMart can help you obtain regulatory approval for your medical device or IVD in China.

• Determine device classification.
• Determine if clinical trials will be needed for your device.
• Ascertain the best route to NMPA approval in China.
• Compile the registration application and Technical Requirement document.
• Coordinate product testing in China.
• Prepare final submissions.
• Handle Supplementary Notice requests (additional information inquiries from the DVDA) and device registration renewals.

• Professional expertise and a strong industry network comprising test laboratories, certification bodies and governmental organizations;
• High-quality prereview of your documentation;
• Efficient communication with the relevant authorities.

STEMart's experienced consultants can provide insight on how to navigate the evolving regulatory landscape in China and guide you through the regulatory process. If you want to learn more detail about our service, or would like to consult with the experts at STEMart, please feel free to contact us.