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China NMPA GMP Inspection Guideline: Preparing for the November 1, 2026 Deadline
China's NMPA has released its final Good Manufacturing Practice (GMP) inspection guideline, which becomes mandatory on November 1, 2026. This episode provides a detailed breakdown of the 200 inspection items, with a special focus on the 39 high-risk critical points that can lead to an automatic inspection failure. We outline a clear, actionable strategy for medical device manufacturers, both domestic and foreign, to conduct gap analyses, update their quality systems, and prepare for the stringent new requirements to maintain market access in China. Key Questions: - What is China's new Medical…
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