ABSTRACT
The manufacturer should first clearly define the intended use of the device [1]. The next step is to consider the applicable classification regulations in force in the country where the product is going to be registered before being marketed. Most countries have their own classification scheme, such as Japan, People’s Republic of China [5], and India. 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 1 of the Global Harmonization Task Force (GHTF/SG1/N15:2006) [8] has made progress and has been taken as a reference in some Asian countries such as Singapore, but it can still 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. Although different in many jurisdictions, they carry remarkable resemblance in most cases, having 4 categories of risks identified and treating in vitro diagnostics in their own right [3]. A large percentage of the products would be in the same class across the globe, but care should be taken to examine individual product classifications carefully. GHTF consolidates the classes as A to D, with A being the lowest risk, and D the highest.
