Why Implement the Medical Device Single Audit Program (MDSAP)?

MDSAP: The Readiness Checklist

MDSAP was developed by the International Medical Device Regulators Forum (IMDRF) to address the ongoing and rapid healthcare technology innovations that resulted in more sophisticated medical devices requiring greater regulator expertise to place into global markets and monitor over time.

MDSAP also addresses the exploding global trade in the medical device sector. Currently five jurisdictions make up the MDSAP consortium. They include Australia, Brazil, Canada, Japan and the United States. There are many countries either acting as observers or preparing to include the MDSAP program as a vital part of fulfilling their Regulatory requirements.

Medical device manufacturers are facing new challenges with being able to manufacture, procure and/or distribute critical medical products and components during this unprecedented period of COVID-19 and for expanding healthcare systems around the world.