Q & A – China NMPA (CFDA)

Medical device/IVD/CDx General Questions

General questions about China Regulatory Organization, NMPA (CFDA), CMDE

Medical device/IVD/CDx CER/Clinical Trials

Clinical Evaluation Report (CER), Clinical Trial and Overseas Clinical Data

Medical device /IVD/CDx Registration

Registration, Renewal, Modification and Innovation Approval

Medical device /IVD/CDx QMS/PMS

Quality Management System (QMS), Post Market Surveillance (PMS) and Overseas Inspection

Medical device /IVD/CDx By Indications

Miscellaneous questions and answers