The Medical Device Single 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.”
Nowadays, it is composed by:
- Therapeutic Goods Administration of Australia
- Brazil’s Agência Nacional de Vigilância Sanitária
- Health Canada
- Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
- U.S. Food and Drug Administration
MDSAP Official Observers:
- The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme
- European Union (EU)
MDSAP Affiliate Members:
- Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT)
- Republic of Korea’s Ministry of Food and Drug Safety
More information about MDSAP Program can be found here.