General Questions
General questions about China Regulatory Organization, NMPA (CFDA), CMDE.
Clinical Trials
Clinical Evaluation Report (CER), Clinical Trial and Overseas Clinical Data.
Registration
Registration, Renewal, Modification and Innovation Approval.
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).