Zhongguo Yi Liao Qi Xie Za Zhi 2018 Feb;42(2):122-124
Center for Food and Drug Inspection of CFDA, Beijing, 100061.
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.