The processes for importing regenerative medicine products into Japan differs depending on if the import is for business purposes or not.
1 Import as a Business
When importing a regenerative medicine product as a business and selling it in Japan, the first step is to obtain a manufacturing and sales license for the importer. Second, a foreign manufacturer’s approval is required for each manufacturing site for those who manufacture in a foreign country. Third, if there is a business operator in Japan that manufactures label replacements a manufacturing license is required for that business operator. Fourth, manufacturers and sellers of regenerative medical products need to obtain approval for each item. Fifth, manufacturers and sellers are required to submit notifications and make public the information contained in the attached documents.
2 Imports other than for business purposes
Import verification is required for imports other than for business purposes. However, import confirmation is not required for imports of products with a monthly supply or less in terms of dosage, administration, and usage. You can find more information on the Ministry of Health, Labour and Welfare website.
3 Prohibition of Importation
Importation of illicit regenerative medical products, etc. is prohibited.
4 Prohibition of advertisement
It is illegal for an overseas distributor to advertise unapproved regenerative medicine products on sales websites, targeting also those in Japan. In many cases, advertising by import agents is also illegal.
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