Information document of the IMDRF Management Committee listing how IEC 62304:2006 (Medical device software – Software life cycle processes) is used in each jurisdiction's regulatory system (as of 2015). In Australia, compliance is used as evidence of meeting the Essential Principles; in Canada and the US, it is a recognized standard that can be used as evidence of conformity or for a declaration of conformity. In Europe, the corresponding EN 62304:2006 is a harmonized standard providing a presumption of conformity. In China, it has been adopted as the recommended (not mandatory) standard YY/T 0664-2008, while in Brazil and Russia the use of standards is voluntary. For Japan (MHLW/PMDA), the standard was not yet referred to, but could be used in a premarket application to rationally explain conformity with the Essential Principles. The document does not set out a common position or an interpretation of the standard.