Medical Device Single Audit Program (MDSAP) Pilot Program
One audit for five markets – Australia, Brazil, Canada, Japan and USA
General
In the past, medical device manufacturers who wished to license their products in Australia, Brazil, Canada, Japan and USA had to demonstrate fulfilment of the national regulatory requirements of each country within different approval processes. This naturally involved a great deal of time and expense. Now, IMDRF (International Medical Devices Regulators Forum) has developed a new unified program – the MDSAP (Medical Device Single Audit Program) – which covers different regulatory requirements.