Q & A – China NMPA (CFDA)

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

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

Registration, Renewal, Modification and Innovation Approval.

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

Find product-specific questions and answers, sorted by the medical device/IVD/CDx product category.

Answers about the risk assessment, in particular for the Periodic Risk Evaluation Report (PRER).