General Questions
General questions about China Regulatory Organization, NMPA (CFDA), CMDE.
Clinical Trials
Clinical Evaluation Report (CER), Clinical Trial and Overseas Clinical Data.
Type Testing
China specific local type testing requirements for IVD, passive and active devices.
QMS/PMS
Quality Management System (QMS), Post Market Surveillance (PMS), Overseas Inspection.
Risk Evaluation
Answers about the risk assessment, in particular for the Periodic Risk Evaluation Report (PRER).
Product Specific
Find product-specific questions and answers, sorted by the medical device/IVD/CDx product category.