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Q&A – China NMPA (CFDA)

Q & A

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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.

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.

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