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:

MDSAP Members

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.

REGULATORY COALITION PRINCIPAL MEMBERS