NMPA published seven guidelines on post-market surveillance for medical device manufacturers in April 2026. These documents establish a mandatory, risk‑based vigilance system under the Medical Device Vigilance Quality Management Standards (Trial), supported by detailed implementation guides for trend reporting, periodic safety update reports (PSURs), risk evaluation, vigilance planning, and inspection checkpoints. This article provides an […]

The post NMPA’s 2026 Post-Market Vigilance Framework: Essential Compliance Guide for Overseas Medical Device Manufacturers appeared first on China Med Device.

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