OMEDtechNews & Events

The FDA has announced that beginning in January 2014 they will begin participating in the MDSAP (Medical Device Single Audit Program). The goal of the program is “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.”

They will join international groups from Therapeutic Goods Administration of Australia, Brazil’s Agência Nacional de Vigilância Sanitária, Health Canada, and Observers – Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency. MDSAP audit reports will suffice in place of routine FDA inspections.

Here is the full MDSAP Pilot announcement.