1C-W1-1755 PDF
PMDAの医療機器審査について
Medical devices cover a wide range of variation, from medical material products (e.g. contact lens, artificial joint, dental implant) or steel instruments (e.g. knife, tweezers) to electrical devices (e.g. pacemaker, defibrillator, radiation therapy machine). In the review of medical device application, it is necessary to evaluate efficacy and safety depending on features of each medical device, which are characterized by a variety of usage information with different levels of risk. Pharmaceuticals and Medical Devices Agency (PMDA) has a great storage of lessons learned from review experiences. We also prepare to review innovative devices which have been developed with the novel technologies. In this presentation, I would like to introduce the review process of medical device in PMDA.