Insights Into The Medical Device Single Audit Program (MDSAP)

By Martina McDonagh, Associate Director of Quality and Compliance

The Medical Device Single Audit Program (MDSAP) is a global initiative intended to accelerate medical device regulatory harmonization by allowing a single regulatory audit to satisfy the requirements of jurisdictions around the world.

MDSAP was spearheaded by the International Medical Device Regulators Forum (IMDRF). IMDRF is a voluntary group of medical device regulators from around the world that came together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF). Its primary aim is to accelerate international medical device regulatory harmonization and convergence while protecting public health and safety.

Regulatory and quality compliance across multiple markets can be challenging for medical device manufacturers when scaling globally. This usually requires multiple dedicated resources to support regulatory audit schedules from all the jurisdictions and can cause disruptions to day-to-day operations.  If this applies to you, then MDSAP could be a solution.