Medical Equipment Sales Flow

In orfer to sell a medical product made by a foreigh manufcaurer in Japan. they must first obtain approval as a “foreighn manufcature”. Then, the Japanese “medical device manufactrering and sales business” files a pharmaceutical application with the Pharmaceutical and Medical Devices Agency (PMDA) on behalf of the foreign manufactrer, and obtains approval to sell the product in Japan.

In the case of Designated Marketing Authorization Holder (DMAH): the applicant is a foreign manufcaturer and approvals & license belongs to the foreign manufacturer. This is called a special foreign approval. The foreign manufcaturer has the right to the approval obtained through application withough relying on the distributor. The foreign manufacturer has the right to the approval obtaiing through application withought relying on the distributor. License belongs to the foreign manufacturer. DMAH maintain compialnce on the license with Quality Manameget System, GVP operation on behalf of foreign manufacturer.