In recent years, China’s healthcare system reform has been continuously deepening, with third-party medical laboratories gradually transitioning from a “supplementary role” to an important component of the healthcare service system. With the introduction of regulations such as the “Basic Standards and Management Specifications for Medical Laboratories”, the requirements for industry access and operational standardization have been clarified, and increasing attention has been paid to compliance issues in the medical laboratory industry. This article systematically outlines the regulatory framework for domestic third-party medical laboratories, covering key aspects such as administrative approvals, quality management, cost control, and industry supervision. It aims to provide actionable guidance for practitioners, and promote the compliant operation and service quality improvement of third-party medical laboratories.
Citation： LUO Yijie, CHEN Yue, LIAO Yan, ZHANG Fengying, WANG Xinyu, WANG Ke. Compliance operation and policy practice of third-party medical laboratories: key points analysis under China’s regulatory framework. West China Medical Journal, 2025, 40(11): 1839-1842. doi: 10.7507/1002-0179.202508024 Copy
Copyright ? the editorial department of West China Medical Journal of West China Medical Publisher. All rights reserved
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