In the last 20 years, the medical device industry has grown by leaps and bounds. Innovations are improving healthcare and diagnosis capabilities, effectively improving human life. What was once done laboriously, using simple instruments, has given way to more complex, sophisticated, and highly efficient devices. Manufacturers intend to take their products beyond their own countries and into global markets at a greater rate than ever. For this, they need to comply with demanding and varied regulatory requirements of the different jurisdictions and the audits. The regulations themselves are quickly evolving and becoming more stringent.
On the other hand, Regulatory Bodies have limited resources and are hard pressed for enough time. They need to keep pace with the rapid developments in the industry while having to ensure that the safety and performance of the devices is not compromised. Patient safety remains the ultimate aim. Therefore, the regulators looked for a single harmonized strategy for regulatory audits.
In this dynamic and vibrant scenario, the Medical Device Single Audit Program (MDSAP) was launched as a solution that allows a single audit of manufacturers against multiple regulatory requirements.
The foundational work done by the Global Harmonization Task Force (GHTF) was taken up by the International Medical Device Regulators Forum (IMDRF) in 2014, which set up a working group to create a harmonized single audit program. The pilot program, launched from 2014-2016, was found effective and therefore in Jan 2017, the MDSAP was officially implemented with five countries participating in it.
MDSAP’s mission is to jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturing.