Abstract
Pharmaceutical Affairs Law (PAL) is intended to provide regulations required to ensure the quality,efficacy and safety of drugs, quasi-drugs, cosmetics and medical devices. It is expected that the development of new products will be promoted further corresponding to the progress of science and technology in the near future. Medical devices are classified into the three categories on international classification and so forth in order to accommodate diverse measures, according to the risk to the human body in association with the uses of various sorts of medical devices. PAL requires medical safety and quality management system as essential principle. In other words, PAL provides useful thought for development.
