Purchase of Third-Party Audit Services of Medical Devices in
Post-market Supervision From MDSAP
HUANG Wanchun1，YANG Jingyi2，DU Ruo2，LIANG Yi1
1. School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing Jiangsu 211198, China丨
2. Department of Medical Device Manufacturing Supervision, Jiangsu Medical Products Administration, Nanjing Jiangsu 210008, China
Abstract：Objective To provide inspiration for purchase of third-party audits services of medical device in China post-market
supervision through the process introduction of regulatory authority recognition and assessment of auditing organizations within the
medical device single audit program (MDSAP). Methods Combined with the relevant work implementation guidelines issued by
international medical device regulators forum and MDSAP work group, recognition requirements and assessment process for medical
device auditing organizations were introduced. Results When purchasing third-party services by learning from international practical
experience, it can be considered from four aspects, including set of qualification requirements for organizations and personnel,
standardization of audit procedures for the third-party organizations, establishment of the decision and address mechanism of audit
results, and study of effectiveness evaluation index system for third-party services. Conclusion Introduction third-party organizations
to assist in some inspection tasks in the post-market supervision of medical devices is conducive to exploring the construction of
social co-governance model and promoting the modernization of the medical device regulatory system.
黄琬纯1，杨静怡2，杜若2，梁毅1. 从MDSAP看医疗器械上市后监管购买第三方检查服务[J]. 中国医疗设备, 2021, 36(8): 138-142.
HUANG Wanchun1，YANG Jingyi2，DU Ruo2，LIANG Yi1. Purchase of Third-Party Audit Services of Medical Devices in
Post-market Supervision From MDSAP. China Medical Devices, 2021, 36(8): 138-142.
