Medical Device Single Audit Program (MDSAP) is a globally recognized initiative aimed at streamlining and harmonizing the regulatory processes for medical devices. This article delves into the MDSAP audit countries, shedding light on the significance of this program and its impact on the medical device industry.
MDSAP encompasses a group of countries committed to ensuring the safety and effectiveness of medical devices through a unified auditing approach. The participating nations include the United States, Canada, Brazil, Australia, and Japan. This collaborative effort allows manufacturers to undergo a single audit that satisfies the regulatory requirements of multiple countries, streamlining the approval process and reducing the burden on industry players.