Processes for importing medical devices and in vitro diagnostic products into Japan differs depending on if the import is for business purposes or not.
1 Imports as a Business
In the case of importing medical devices and in vitro diagnostic products as a business and selling them in Japan. First, the business operator conducting the importation is required to obtain a manufacturing and sales license. Secondly, registration of foreign manufacturers is required for each manufacturing site for business operators who manufacture in foreign countries. Third, if there is a business operator in Japan that manufactures label replacement, that business operator is required to register as a manufacturing business. Fifth, the manufacturer or distributor must submit a notification and make it public with regard to the matters described in the attached document.
2 Imports other than for business purposes
Import verification is required for imports other than for business purposes. However, in the case of contact lenses, importation of two pairs (two-month supply for disposable lenses) does not require import verification. You can find more information on the Ministry of Health, Labour and Welfare website.
3 Prohibition of Importation
The importation of illicit medical devices and in vitro diagnostic products is prohibited.
4 Prohibition of advertisement
It is illegal for overseas distributors to advertise unapproved/uncertified medical devices and in vitro diagnostic products on sales websites, even to those in Japan. In many cases advertising by import agents is also illegal.
Please contact us if you have any questions.