Basic Approach of Biological Evaluation of Medical Devices for Pre-Market Applications

Abstract

The Pharmaceuticals and Medical Devices Agency (PMDA) is regulatory agency in Japan and reviews for marketing approval of pharmaceuticals and medical devices. In accordance with the Pharmaceutical Affairs Act, PMDA evaluates the efficacy, safety, and quality of drugs and medical devices for which applications have been submitted for regulatory approval, based on the current scientific and technological standards. The biological evaluation of any material or medical device intended for use in humans should part of a structured biological evaluation plan within a risk management process. When assessing new medical devices, the sponsor should evaluate the biological responses that are regarded as adverse, caused by materials in one application. This paper described how the sponsor should approach to the biological evaluation on medical devices.