ABSTRACT
Several countries other than those which are the main focus of this book, i.e. the European Community, Japan and USA, are in process of introducing or revising medical device regulations. Several factors seem to be responsible: economic and technical developments have resulted in medical devices appearing in countries from which they were formerly absent; public anxiety has been aroused by the Bjork-Shiley heart valve (Lindblom et al. 1989) and breast implant (Snyder 1997) problems; the influence of the US and EC regulations is being felt in countries exporting to these regions; publicity about the Global Harmonization Task Force, etc.
