The Medical Device Single Audit Program (MDSAP) is a program initiated by the International Medical Device Regulators Forum (IMDRF). Under this program a single audit, performed by an authorized Auditing Organization (AO) would meet the QMS surveillance requirements of multiple regulatory authorities. Participating countries are Brazil, Canada, Japan, and the United States.
From January 1, 2017 to December 31, 2018, Health Canada will accept both MDSAP and CMDCAS (Canadian Medical Device Conformity Assessment System) certificates. From January 1, 2019, onwards Health Canada will accept only MDSAP certificates.
The transition to MDSAP aligns with the transition plan for QMS certificates from ISO 13485:2003 to ISO 13485:2016.