General Questions
General questions about China Regulatory Organization, NMPA (CFDA), CMDE.
Clinical Trials
Clinical Evaluation Report (CER), Clinical Trial and Overseas Clinical Data.
QMS/PMS
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).