MDSAP

MDSAP Overview:  The Medical Device Single Audit Program (MDSAP) is a program where Auditing Organizations (AO) conduct a single audit of a medical device manufacturer’s quality management system that would be accepted by all five Regulatory Authorities currently participating in the program, Australian TGA, Brazilian ANVISA, Health Canada, US FDA and Japanese MHLW. The program becomes mandatory for Canada as of January 1, 2019 when the current CMDCAS program is terminated.  This course provides an overview of the requirements of the MDSAP program with guidance on the specific requirements of the program.  It also provides a link to other courses that with more an in-depth country-specific training.