Medical Device Single Audit Plan (MSDAP)
The MDSAP is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions.
MDSAP relates to ISO 13485 and is required if an SaaMD is marketed in Canada, Japan, and Australia, among others.
MDSAP is not required in the United States, though the FDA does acknowledge MDSAP Audits.
The equivalent to MSDAP for Europe are the Medical Device Directives (MDD), which are soon to be replaced by the Medical Device Regulations (MDR).