ABSTRACT
The far-reaching economic and political turmoil that has rocked Asia continues to have profound repercussions both in the countries of the region and throughout the rest of the world. Medical device regulation should ensure that the product is safe, is of high quality and performs to the specifications intended by the manufacturer under stated conditions. The European Union has already established a very credible review system for medical devices through efforts such as basing the process on quality system standards, using the world-class, globally recognized International Standards Organization 9000 series of standards. In fact, as countries update their regulatory procedures, most are following the lead of Europe. The American National Standards Institute can identify the particular Japanese Industrial Standards for specific products and provide a copy of these to companies for a fee. The Japanese Standards Association was established as a public institution for the promotion of industrial standardization on December 6, 1945, under government authorization.
