Category: Immunology

NMPA’s Review Points for Tumor Gene Variation Detection Reagents: Key Highlights and Implications

July 9, 2026

The NMPA issued the “Technical Review Points for Tumor Gene Variation Detection Reagents (Trial)” on June 15, 2026. This guidance covers NGS‑based IVD reagents for tumor mutations, which are essential

Four Medical Devices Receive NMPA Innovation Approvals in One Week

November 12, 2021

The NMPA granted Innovation Approval to four medical devices in the first week of November 2021: Zhongyi Kangwei: Preimplantation Chromosome Aneuploidy Detection Kit Zhuo Ruan Medtech: Biological Hernia Repair Patch

Category: Immunology

NMPA’s Review Points for Tumor Gene Variation Detection Reagents: Key Highlights and Implications

Four Medical Devices Receive NMPA Innovation Approvals in One Week

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NMPA (CFDA) Updates

China’s New GMP Takes Effect Nov 1, 2026, as NMPA Issues Four New Inspection Guidelines

NMPA Clinical Trial Guideline on Implanted BCI Hand-Movement Compensation System: Key Focus on Patient Eligibility, Clinical Endpoints, and Lifecycle Evidence

Inspection Points for IVD Reagents: Centering on Control of Contamination, Traceability and Contract Manufacturing

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China’s New GMP 2025 – What Every Global Manufacturer Must Prepare Before Nov 1, 2026

Key Takeaways and Best Practices of China Human Factor/Usability

202505 NMPA News Roundup

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