Studies on laws and standards in health care business for medical innovation

Abstract

We have to cope with various kinds of laws and standards. In medical and the health care industry, the Pharmaceutical Affairs Law is important. Establishment of the quality control organization of a product is also required. Furthermore, we have to examine international standards, such as not only a domestic standard but also ISO and IEC. Examination of these laws and standards may lack in the innovation model from research to sale. This research examines law and a standard required for a medical enterprise.