JAPAN IS THE THIRD LARGEST COUNTRY FOR MEDICAL DEVICES
With an aging population and mature healthcare system, Japan has historically been the third largest market for medical device sales in the world. The country’s expertise in electronics has also made it one of the hubs for manufacturing high-technology devices. To support its high demand, Japan imports about twice as many medical goods as it exports with the U.S. being both the top export and import country for Japan medical devices.
The Japan Pharmaceutical Affairs Law from the MHLW took effect on April 1, 2005. This law forms the basis for the regulation of medical devices in Japan. The regulations include medical devices and in-vitro diagnostic devices and employ a set of rules to classify each device into a risk-based classification. The higher risk class 3 and 4 devices must be evaluated by the PMDA (Pharmaceuticals and Medical Devices Agency — prefectural agency of MHLW); however, most Class 2 devices, where a Japanese Industrial Standard (JIS) exists, can be evaluated by a third-party organization. Importers are also required to appoint a Marketing Authorization Holder (MAH) as their legal representative in Japan and are subject to an annual quality management system audit, based on ISO 13485, which can be conducted by an authorized private organization.