Japan is the second largest medical device market in the world, with a universal health insurance scheme that contributes to the delivery of high-quality medical services and products. Medical devices are frequently supplied to hospitals through distributors, who play an important role in providing technical support for healthcare professionals. The regulatory framework for medical devices in Japan is strict, with marketing authorization holders responsible for quality control and post-sale safety management. Regulatory approval is required for each device, and clinical trials may be necessary to verify efficacy and safety. The Ministry of Health, Labour and Welfare has been working to shorten the regulatory evaluation process.
