Zhangye Market Regulators Enhance Medical Equipment Safety Oversight

Deep News
Feb 28

The Zhangye Municipal Market Regulatory Authority in Gansu Province has recently intensified efforts to ensure the quality and safety of medical equipment by carrying out in-depth risk investigation and remediation work. The initiative focuses on three key areas.

First, the authority is identifying potential hazards and strengthening supervision. Targeting medical institutions as the primary entities, it is conducting comprehensive inspections of high-frequency/radiofrequency electrodes (Class II) and tissue closure clips (Class II), among other key product categories. The inspections thoroughly verify product sourcing channels, qualifications, clinical usage, and quality management systems. Medical equipment users are urged to strictly fulfill their legal obligations and comply with regulations such as the "Measures for the Supervision of the Quality of Medical Device Use."

Second, emphasis is placed on collaboration to promote standardization. By enhancing coordination with the health department and using regulations as a foundation, the authority clarifies departmental responsibilities. It facilitates real-time sharing of supervision data related to equipment usage. For identified issues, both departments work together to find solutions, avoiding delayed responses caused by information silos and achieving a synergistic governance effect greater than the sum of its parts, thereby solidifying the baseline for medical equipment quality and safety.

Third, the authority is deepening publicity to improve quality and efficiency. Adhering to the principle that "enforcement is also普法 (law popularization)," officials actively educate medical institutions on relevant laws and regulations during risk assessments, urging them to uphold their primary responsibility for the quality and safety of medical equipment used. For specific questions from individual institutions regarding system establishment, staff training management, and quality tracking, proactive policy interpretation is provided. Through guidance and collaborative governance, the aim is to further standardize the use of medical equipment by medical institutions, prevent safety risks, and safeguard public safety when using medical devices.

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