When selling pharmaceutical and medical device products to Japan, EU companies may consider 3 options, namely use of a Japanese distributor, direct sales to end customers, or commercial licensing to a Japanese company.
Major administrative licences needed for manufacture, importation and marketing of pharmaceutical products and medical devices in Japan include (1) marketing business licence for distributors, (2) anufacturing business licence for manufacturers in Japan, (3)accreditation for foreign manufacturers who supply products to Japan and (4) marketing authorization for each product.
In case of extremely urgent cases, however, Japan may exempt some rules on licensing as it was seen recently on certain treatments related to Covid-19. As for medical devices, while suppliers are not required to have specific certifications or licenses to sell products to medical device manufacturers, there are some Japan-specific standards, such as Japanese Industrial Standard (JIS), that EU suppliers need to comply with.
EU small- and medium-sized enterprises (SMEs)
Please find more information here and register for the event by 1 February 2022.