Explanation for Notification and Precautions of Medical Laser

Abstract

In the result of discussions between industry, academia and government, yakuseikishinhatsu 0629 No. 4 ‘Management of medical laser application for approval’ was notified. The new notification shows not the range of specification without clinical trial but the guideline for development of medical laser including laser scalpel, which is mainly composed of non-clinical evaluation items and basic concepts of indication for use and necessity of clinical trial. The consultation with pharmaceuticals and medical devices agency is recommended for the decision that it is possible to evaluate the differences between devices with only non-clinical testing. Additionally, it is important for medical devices to take safety measures for the post marketing, which is not subjected to the notification but one of the review points for approval. Especially, it should be noted that safety manager selection and safety management area setting are essential for medical laser use. It is significant for resolving the clinical problems relative to medical laser to keep discussing continuously and cooperating closely with industry, academia and government.