Proposals and prospects for a global regulatory system for medical devices

This book has described the emergence of regulations for medical devices during the 1960s and 1970s, the transition (still in progress) from the treatment of medical devices as a particular type of pharmaceutical to an engineering approach, and the identification of features regarded as ‘key’ in any system for assuring the safety and satisfaction of medical devices. The general acceptance of these key features and their prominence in the most recent regulations are evidence of trends leading regulatory authorities towards a common approach which offers prospects of a global regulatory system at some point in the future (Higson 1995). This process has been led in the last few years by the Global Harmonization Task Force (Higson 1996), supported by ISO Technical Committee 210.