Objective: The post marketing regulatory system of medical devices in China has been underreported. Little research effort has been made to identify the major areas of concerns for actions of improvement. The study aimed to systematically analyze the policy development process and the regulatory status of the post market regulatory system or medical device in the country. It is anticipated that the findings will help inform policy recommendations for the improvement of the regulatory system. Methods: This study employed policy document review and literature review to collect the relevant policies and regulations of China's medical device post-marketing surveillance, depict the development status of China’s medical device post-marketing supervision and regulation, and analyze the relevant data and reports of medical devices' post-marketing surveillance. Results: The study summarized the development history of relevant policies and regulations of medical devices' post-marketing surveillance in China. China has established a complete post-marketing regulatory system for medical devices. At present, the post-marketing regulatory system of medical devices can be divided into three parts: daily supervision, adverse event monitoring, and re-evaluation and recall. Data shows that the promulgation of relevant policies and regulations has had a positive impact on the status of China's devices surveillance, but there are still many challenges. The development of regulatory science has played a positive role in the development of regulatory policies. Conclusion: China has established a complete post-marketing regulatory system for medical devices. In the face of the current challenges, regulatory science should be developed to drive the development of regulation, requiring the joint efforts of all sectors in the pharmaceutical system. Keywords: Medical devices; Post-marketing surveillance; Regulatory science; Policies; Adverse events; Recalls

目的 中國醫療器械的上市後監管體系已初步建成，但該體系目前亟待進一步完善，且目前針對上市後監管體系的系统性研究较少。本文旨在整理中國上市後監管體系的政策發展過程，分析各個環節的監管現狀，為我國醫療器械監管部門的政策制定提供依據，並為監管體系的完善提出政策建議。 方法 本研究採用政策文件回顧、文獻綜述等研究方法，系统收集整理了中國醫療器械上市後監管相關的政策法規，了解我國醫療器械上市後監管法規發展現狀，在納入了醫療器械上市後的相關數據和報告後進行系統分析。 結果 研究總結了中國醫療器械上市後相關法規的展史，我國已建立起较為完善的醫療器械上市後監管體系。目前醫療器械上市後監管可分為日常監管、不良事件監測與再評價、召回三個環節。數據顯示相法規的頒布對我國器械監管現狀起到了積極影響，但仍存在著不少挑戰。監管科學的發展對醫療器械上市後監管政策的發展起到了積極作用。 結論 目前我國上市後監管體系建設已較為完善，但各環中存在的挑仍然需要結合監管科學的發展和應用以解決，這也需要社會各界共同努力。 關鍵詞：醫療器械；上市後監管；監管科學；政策；不良事件；召回