The Japanese market for medical devices is one of the largest in the world. There’s a lot of potential for foreign manufacturers: imports account for roughly half of the Japanese market. In order to enter the market one needs to understand the special characteristics of the Japanese market, especially the specific distribution channels and the complex legal system.

Only a small percentage of equipment is sold directly from manufacturers and import retailers to hospitals and end users. There’s a retail pattern in which sales are made via medical equipment dealers. 
More fundamental is the new Pharmaceutical Affairs Law (PAL) that has been launched in 2005. Under this law medical equipment is required to receive approval, licensing and notification. The law introduces Third Party auditing and product review for all class II devices (low to medium risk). Certification standards are only available for selected products from these categories. 

KEMA is working hard to become accredited under this new law. ’We put a strong effort towards obtaining third party accreditation under the new Japanese PAL. The first step, establishment of KEMA Japan has been finalized. Currently the last sections on the formal application are being completed’, Mr. Buijzen said. Buijzen, project leader at KEMA is very familiar with the Japanese culture and the special way of doing business in Japan. Also his background as an industrial pharmacist is very useful as the new law is partly derived from medicinal regulation and GMP requirements. 
After accreditation we can assist you with an easier and faster access to the Japanese market by providing you one-stop shopping. We will update you through our newsletter and project managers.