As a core element of the national quality infrastructure, accreditation plays a vital role in promoting the high-quality development of medical laboratories in China. By establishing and implementing a quality management system that meets international standards, medical laboratories obtain accreditation, which enhances their technical capabilities, ensures the accuracy of test results, and supports scientific clinical decision-making. This paper systematically reviews the major progress in the accreditation of medical laboratories in China, including the number, types and scope of accredited laboratories, the status of assessment against to ISO 15189:2022, and the current acceptance of accreditation outcomes. It also analyzes key challenges facing current accreditation effort, including the in-depth interpretation and implementation of ISO 15189:2022, the accreditation of point-of-care testing (POCT) and emerging technologies or methodologies, and the insufficient endogenous motivation for continuous improvement in some laboratories. Finally, targeted countermeasure suggestions are proposed, aiming to provide a reference for improving the accreditation system of medical laboratories and promoting the high-quality development of the industry in China.