对医疗器械单一审核程序中见证检查工作的思考

摘要

Medical Device Single Audit Program is one of the key projects in International Medical Device Regulators Forum, which has much experience to be used for reference. This paper briefly describes the procedures and contents of the Witnessed Audit in Medical Device Single Audit Program. Some revelations about the work of Witnessed Audit have been discussed, for reference by the Regulatory Authorities and the Auditing Organizations.%医疗器械单一审核程序是近年来国际医疗器械监管论坛设置的重点工作项目之一,具有很多值得借鉴的经验.该文简单概述了医疗器械单一审核程序中见证检查的流程和内容.同时,初步探讨了见证检查对监管工作的一些启示,供监管部门、检查机构参考.