China Green Pathways: Expedite your Market Entry in China

2023 China NMPA Bluebook is here:

Q&A – China NMPA (CFDA)

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Medical Electrics Standards Effective May 1, 2023; Grace Period Granted

March 17, 2023

New IVDs Classification Catalog Proposed by NMPA

March 16, 2023

NMPA Roundup February 2023

March 10, 2023

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).

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