Single-Audit Pilot Rolls Out in January, Starts with CMDCAS Registrars

The International Medical Device Regulators Forum will launch its medical device single audit program (MDSAP) pilot in January in the U.S., Canada, Australia and Brazil. The program will run for three years in pilot phase and has the potential to overhaul many FDA inspection and enforcement activities. For devicemakers, the benefit is that a single inspection could eventually serve all IMDRF nations, taking the place of the routine audits currently conducted separately.
Devices & Diagnostics Letter