Medical Device Single Audit Program – MDSAP

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The Medical Device Single Audit Program (MDSAP) is a program that allows medical device manufacturers to undergo a single regulatory audit by an authorized auditing organization. It has to satisfy the requirements of multiple regulatory authorities. These includes the US FDA, Health Canada, TGA Australia, Japan MHLW/PMDA, and Brazil ANVISA. The MDSAP allows manufacturers to meet the regulatory requirements of these countries and streamline the audit process, reducing the overall regulatory burden. The program was launched in 2014 and has since been adopted by several countries as a means to streamline regulatory compliance for medical devices.