Medical Device Single Audit Program (MDSAP)

UL International Germany GmbH

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UL’s Medical Devices Single Audit Program (MDSAP) helps manufacturers meet the quality management system (QMS) requirements for participating countries with a single QMS audit. MDSAP is based on International Medical Device Regulators Forum (IMDRF) quality system recommendations, and regulators currently participating in the program include the U.S. FDA, Health Canada, the Australian Therapeutic Goods Administration (TGA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and Brazil’s National Health Surveillance Agency (ANVISA).

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