ABSTRACT
The classification of rules for active medical devices in some jurisdictions differs from the medical devices ones. It is the responsibility of the manufacturer to determine the classification of its medical device as early as possible in the device development. According to Global Harmonization Task Force standards, in vitro diagnostic medical devices are classified into four classes, based on the individual risk and public health risk level. The classification schemes of Canada and Australia/New Zealand resemble the European one, whereas the one in the United States is different. Efforts are under way to effect a global harmonization of classification. For instance, Study Group one of the Global Harmonization Task Force has made progress and has been taken as a reference in some Asian countries such as Singapore, but it can be noticed that systems differ and it is the up to the manufacturer to check and adapt its medical device class to the appropriate local classification scheme.
