What is a Medical Device Single Audit Program?

Medical Device Single Audit Program Definition

The medical device single audit program (MDSAP) is a program that allows for a single regulatory audit of a medical device manufacturer’s quality management system. This single audit satisfies the regulatory requirements of up to five different medical device markets (i.e., Australia, Brazil, Canada, Japan, United States).

Related Terms

  • International Medical Device Regulators Forum (IMDRF)
  • Food and Drug Adminstration (FDA)
  • Health Canada (HC)
  • ANVISA
  • Therapeutic Drugs Administration (TGA)
  • MHLW/PMDA