Our message
Japan MDC is a leading consulting firm for Medical Devices
Japan currently faces serious problems Japanese Medical Market Environment. This demographic trend serves to increase the incidence rates of cancer, cardiovascular disorders and lifestyle-related diseases such as diabetes and hyperpiesia. Despite this background, the situation is hindered by a social problem in which new medical devices in Japan are approved around 10 years later than in other countries. The complexity and difficulty of Japanese Regulatory Environment is one of the major factors contributing to the issue of device lag. The government and related authorities have worked to achieve their goal of delivering better medical devices to patients faster in cooperation with industry groups. Some success has been achieved in improving regulations, the registration system and other related issues, but work is still in progress. Against this background, those hoping to enter Japanese Market Environment must clearly understand the current regulations and regulatory systems, and make effective strategies to meet the requirements.
Japan MDC is a government-licensed firm as a MAH; we provide a full range of specialized regulatory consultant for Medical Devices involving closed communication with its clients and with the authorities; this reflects the high value we place on communication to achieve faster approval.
Obtaining regulatory approval is not the final goal; rather, it is the beginning of your business strategy process. Our wealth of experience with a variety of medical products and technologies enables us to create strategic approaches with sincerity and passion that allow clients to achieve their goals in introducing medical devices to the Japanese market.
