Unlike pharmaceuticals, not all medical devices require clinical trials during the development process. In Japan, the regulatory pathway for medical devices is determined according to their risk classification and level of novelty, with products subject to notification, certification, or regulatory approval. Clinical trials are generally required only for certain new or improved Class II–IV medical devices that undergo approval review by the Pharmaceuticals and Medical Devices Agency (PMDA). Even when formal clinical trials are unnecessary, clinical research remains essential for continuously evolving medical devices to assess not only their safety and effectiveness but also their performance and usability. As a result, exploratory clinical studies aimed at supporting product development and commercialization are widely conducted.
GREEN8 Japan provides comprehensive logistical support for Japan domestic clinical trials, international multicenter clinical studies, and overseas clinical trials. We also offer access to GMP-certified manufacturing facilities to support your development and production needs in Japan. Please feel free to contact GREEN8 bilingual staff to discuss how we can assist your medical device development program for the Japan market.
