Medical Device Single Audit Program (MDSAP): Announcement to manufacturers

Under this pilot, manufacturers that market medical devices and in vitro diagnostics in Australia, Brazil, Canada, and the US can volunteer to be inspected by a MDSAP-recognized third-party organization. Medical device regulators in the participating countries will be able to use these inspection reports when making their regulatory decisions. This will decrease the number of regulatory audits manufacturers have to host, thereby minimizing manufacturing plant and personnel disruptions. This summer manufacturers that market medical devices and in vitro diagnostic in Japan will also be invited to participate in the pilot.

The manufacturers that participate in the process during the pilot will help shape the policies and procedures for the operational program scheduled to begin in 2017. FDA has posted four new documents on the Pilot MDSAP which describes up to date information on how the five participating Regulatory Authorities will utilize the MDSAP Pilot Audit Reports to reduce audit burdens on manufacturers and leverage regulatory resources.

FDA Voice Blog: Australia, Brazil, Canada, Japan, and the US: Safeguarding Medical Devices [http://blogs.fda.gov/fdavoice/index.php/2015/01/australia-brazil-canada-japan-and-the-us-safeguarding-medical-devices/]

2015 MDSAP Announcement to Medical Device Manufacturers [http://www.fda.gov/downloads/MedicalDevices/InternationalPrograms/MDSAPPilot/UCM429958.pdf]

Q & A Medical Device Single Audit Program [ http://www.fda.gov/downloads/MedicalDevices/InternationalPrograms/MDSAPPilot/UCM430563.pdf ]

MDSAP Pilot Eligible AOs [ http://www.fda.gov/downloads/MedicalDevices/InternationalPrograms/MDSAPPilot/UCM429978.pdf ]