Medical Device Single Audit Program (MDSAP)

The Medical Device Single Audit Program is a global approach to auditing and monitoring the manufacturing of medical devices. This program, launched in January 2014 like a Pilot Program with the participation of Health Authorities from Brazil, Australia, Canada, US and Japan, have the mission of “strategically accelerate international medical device regulatory convergence to promote an efficient and effective regulatory model for medical devices that is responsive to emerging challenges in the sector while protecting and maximizing public health and safety.

In 2019 the category of MDSAP Affiliate Member was created: “A non-participating MDSAP Observer or non-participating MDSAP RAC regulatory authority that wants to engage in MDSAP, demonstrates understanding of MDSAP and utilize MDSAP audit reports and/or MDSAP certificates for evaluating a medical device manufacturer’s quality management system.”

The MDSAP is a global approach to auditing and monitoring the manufacturing of medical devices. The MDSAP allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

Nowadays, it is composed by: