What is PMDA certification for exporting pharmaceuticals/medical devices to Japan?

The PMDA (Pharmaceuticals and Medical Devices Agency) is the organization responsible for the approval and review of pharmaceuticals and medical devices in Japan. To export medical devices to Japan, PMDA approval is required.

Japan is the third largest medical device market in the world. With an aging society, the demand for medical devices continues to rise. The regulatory system is relatively similar to that of Korea, making entry into the market easier.

Japanese medical devices are classified into four grades based on their risk levels. The registration procedures and timelines vary significantly depending on the grade.

Registering medical devices in Japan starts with securing a MAH (Marketing Authorization Holder). Korean companies need to designate a Japanese partner or agency as the MAH.

The registration costs for medical devices in Japan vary significantly depending on the Class. This has been organized based on the standards as of 2026.

Korea and Japan have similar medical device regulations. By leveraging MDSAP or the similarities between Korean and Japanese regulations, entry becomes easier.

Entering the Japanese market can be supported by KOTRA's Japan Trade Center and the Korea Medical Device Industry Association. You can also receive assistance for PMDA registration costs through export vouchers.