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. 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).
Beginning in January 2014, FDA will be participating in a MDSAP Pilot alongside other international partners. FDA will accept the MDSAP audit reports as a substitute for routine Agency inspections.
The MDSAP Pilot is intended to allow MDSAP recognized Auditing Organizations to conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the medical device regulatory authorities participating in the pilot program.
International partners that are participating in the MDSAP Pilot include:
- 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
- The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) are Official Observers
MDSAP Participant Survey
Medical Device Firms and Auditing Organizations participating in the Medical Device Single Audit Program are invited to provide feedback through targeted surveys: