MDSAP – Medical Device Single Audit Program

If you are a medical device manufacturer, take advantage of the MDSAP.

 This unique program for Medical Devices manufacturers allows you to apply for a single assessment of your quality management system (QMS) valid for all five participating countries: United States, Canada, Brazil, Australia, and Japan.

 In Brazil, ANVISA resolution RDC 16/2013 specifies the requirements regarding the Brazilian Good Manufacturing Practices (BGMP) for manufacturers of class III and IV medical devices.

 The GMP certification is obtained through ANVISA’s audit, review of your QMS documentation, or through the analysis of the MDSAP (Medical Device Single Audit Program) audit report.