NMPA Proposes Ten Measures to Support Innovative Development of High-End Medical Devices

On June 20, 2025, the National Medical Products Administration (NMPA) held a meeting to review and adopt the Measures for Optimizing Whole-Life-Cycle Regulation to Support the Innovative Development of High-End Medical Devices (the "Measures").

The Measures set out ten aspects: optimizing special approval procedures, improving classification and naming principles, strengthening the standards system, clarifying registration review requirements, enhancing communication guidance and expert consultation mechanisms, detailing post-marketing regulatory requirements, reinforcing quality and safety monitoring, tracking industry development, advancing regulatory science research, and promoting global regulatory harmonization.

The Measures aim to deepen comprehensive reforms across the full life cycle of drug and medical device regulation, while outlining targeted support priorities in the high-end medical device sector.