Q&A – China NMPA (CFDA)

General Questions

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

Clinical Trials

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.

Product Specific

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

Risk Evaluation

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

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