2020 Volume 58 Issue 2-3 Pages 86-92
Medical devices are regulated by Pharmaceutical and Medical Device Act (PMD Act) in Japan. Academic researchers usually do not have much opportunity to know the detail of regulation. In this article, outline of medical device regulation and way of thinking of non-clinical/clinical evaluation are introduced. Whether a device is regulated as medical device or not depends not on the technology, but on the purpose of the device. Regulated medical devices are classified into four classes depending on its risk;class 1 has lowest risk, and class 4 has highest risk. Regulatory hurdle changes according to the class. Medical device companies are also the target of regulation depending on their role;market authorization holder, manufacturer, distributor, and so on. Non-clinical and clinical evaluations are required to get approval or certification before marketing. Evaluation items differ depending on the characteristics of each medical device. Clinical trial is required only when safety and efficacy cannot be proven without clinical trial. Otherwise, non-clinical trial including performance test, biological test, animal test, is enough. Even if clinical trial is necessary, double-blinded randomized control trial is not always required. Small number of clinical use reports are sometimes enough. Recently, the balance between pre-marketing evaluation and post-marketing evaluation is changing. Regulation of medical device keeps changing, thus deep consideration and discussion with Pharmaceutical and Medical Device Agency (PMDA) are recommended.
