Q & A – China NMPA (CFDA)

China Med Device team compiled this China Medical Device Registration & Regulatory Q&A list that is intended to guide you by quick answers on common questions about China type testing, clinical evaluation, medical device CFDA/NMPA registration, quality assurance and post-market surveillance.

For more information or copies of English-translated NMPA (CFDA) regulations, please contact us by email info@ChinaMedDevice.com

Medical device/IVD/CDx Clinical Trials

How to handle clinical trials data information and filing procedures

Medical device /IVD/CDx Registration

Registration certificates, registration renewals, and innovation approval

Medical device /IVD/CDx Quality Assurance

Chinese Overseas Inspections

Medical device /IVD/CDx By Indications

Miscellaneous questions and answers