FDA
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Medical Device Single Audit Program (MDSAP)
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Medical Device Single Audit Program (MDSAP)
The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory Jurisdictions. At its inaugural meeting in Singapore in 2012, the IMDRF identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).
International partners that are participating in the MDSAP include:
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
MDSAP Background
MDSAP was developed by the International Medical Device Regulators Forum (IMDRF) to address the rapid innovation that has resulted in more sophisticated devices that require greater regulator expertise to monitor. MDSAP also addresses the exploding global trade in the medical device sector. For example, in 2015, FDA-regulated products accounted for about 10% of all imports into the US, arriving from more than 300,000 facilities in 150 different countries.
MDSAP Implementation & Participating Country:
- Australian Therapeutic Goods Administration (TGA)
- The Brazilian National Health Surveillance Agency ANVISA (Agência Nacional de Vigilância Sanitária)
- Health Canada (HC)
- US Food and Drug Administration, Center for Devices and Radiological Health (CDRH)
- Japan Ministry of Health, Labor and Welfare
Potential Benefits of MDSAP for Medical Device Organizations
Device manufacturers that choose to participate in MDSAP may expect:
- Reduces the number of audits and inspections a manufacturer must undergo
- Consistency of multiple, international regulatory programs by participating regulators
- More predictable audits and outcomes through:
- Using a standard MDSAP audit model
- Grading of nonconformities using objective criteria to characterize the significance of the finding(s)
- Reporting of audit outcomes using a standard report template
- Monitoring of the AOs by the participating regulatory authorities
- More efficient marketing authorization applications in countries where a quality management system audit is a prerequisite
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