Update on Japan Cabinet Order No. 362 and MHLW Notification No. 0331-20 and US FDA Authorized Devices as Equivalent

By Kenji Yashiro, Amber Baade, Kim M. Guerrero and Evangeline Loh

Background on Cabinet Order No. 362

We previously reported that the Ministry of Health, Labour and Welfare (MHLW) in Japan acknowledged the U.S. Food and Drug Administration (FDA) as an equivalent regulatory authority for priority review in Cabinet Order No. 362 of 2025. 

At the time, Emergo by UL experts had understood this to mean that medical devices already authorized in the U.S. that have a “predicate” device registered in Japan and are considered a me-too device, will be granted priority review in Japan. This is still the case. However, it is now clear that this is related to supply shortages.

Recognition of U.S. FDA as equivalent

MHLW Notification No. 0331-20 (March 31, 2026) published a procedure for priority reviews in the case of supply shortages in Japan, taking into account previously implemented expedited procedures and the new provisions regarding priority reviews and investigation of overseas substitutes in times of supply shortage that were newly established (Article 23-2-5, paragraphs 9 and 10 of the Pharmaceuticals and Medical Devices Act).

The MHLW Notification specifies that the demand for the device in Japan must be high, the currently available devices in Japan cannot meet the demand, and of course, the device is already authorized by the U.S. FDA. Finally, the notification describes the submission that must be made to the MHLW for the consultation, as the MHLW must agree that the device is subject to the priority review. 

Concluding remarks

While this regulatory reliance development in Japan is limited to devices which are in short supply (among other considerations), it is still a first step for regulatory reliance for the MHLW. 

We continue to support the benefits of regulatory reliance globally and will monitor developments related to this priority review route in Japan.