被授权的审核机构(Auditing Organization)通过对制造商的质量体系进行审核,以评估所适用的国家的法规的要求是否已经融入了生产企业的质量体系并有效地运行,并作出MDSAP证书的发证的决定。 MDSAP参加国的法规要求: 美国: 21 CFR Part 803 - Medical Device Reporting 21 CFR Part 806 - Reports of Corrections and Removals 21 CFR Part 807 (Subparts A to D) - Establishment Registration and Device Listing 21 CFR Part 820 - Quality System Regulation 21 CFR Part 821 - Device Tracking