A Seven Step Approach to Market Entry - With a total volume of 24 billion Euro a year, Japan is the world's second largest medical device market behind the US1. It imports about 35% of the medical devices from abroad. With ageing population the imports has been increasing steadily over the past years. Still, Japan is said to have access to only half of the advanced medical devices that are available in the US and Europe. This is most likely due to the fact that regulatory clearance in Japan is being considered as one of the most difficult in the world. However, in an effort to ease market access, Japanese Ministry of Health, Labour and Welfare (MHLW) has been implementing an action programme focusing on highly-needed medical devices for faster approval review. Their effort has already achieved results with shorter review period and less cumbersome procedures for application. Entry into Japan is furthermore facilitated by the presence of Registered Certification Bodies in Europe, for instance in the Netherlands. This means that products can be certified for the Japanese market close to home./
How can you as Dutch producer and exporter of medical equipment enter this huge market?
This information sheet describes the commonly used business models and the seven steps needed to successfully enter the Japanese market.
Source: Dutch Embassy in Tokyo