November 26, 2025
By Kenji Yashiro, Amber Baade, Kim M. Guerrero and Evangeline Loh
The Ministry of Health, Labour and Welfare (MHLW) in Japan published (October 31, 2025) Cabinet Order No. 362 of 2025, which revises the Order for Enforcement of the Pharmaceuticals and Medical Devices Act and related orders.
The three changes announced are: provisions for the MHLW to request the Pharmaceuticals and Medical Devices Agency (PMDA) to conduct witness inspections of designated highly controlled medical devices; with Notification No. 1031-10 (October 31, 2025) revises the term clinical studies for pre-marketing approval of IVDs; and acknowledgement of the United States Food and Drug Administration (FDA) as an equivalent regulatory authority for priority review.
These changes will take effect May 1, 2026.
Details related to the recognition of the US FDA as equivalent
The FDA has been recognized as an equivalent regulator. We at Emergo by UL understand this to mean that medical devices already authorized in the U.S. (registered) that have a “predicate” device registered in Japan and are considered a me-too device, will be granted priority review in Japan. This of course does not apply to devices with new intended uses or novel principles of operation.
Details are expected to be clarified in announcements or guidance released by the MHLW by May 1, 2026.
Our commentary on “predicate” device
We use the term “predicate device” in our discussions; the literal translation of the original Japanese term is “existing device.”
From Japanese PMC or PMA applications, the following conditions apply to qualify as an existing device: must be registered as a medical device in Japan, must be within the same device classification (device class and Japanese Medical Device Nomenclature (JMDN) term), and no differences in the intended use, indications, principle, mechanism/mode of action, or materials that come into contact with the human body.
Looking forward
This is an exciting regulatory development as it is the first time that Japan has advanced a form of regulatory reliance.
However, even if a device has been authorized by the FDA, the device must be considered a predicate to a device already marketed in Japan in order to qualify for priority review.
Our Emergo experts continue to monitor for additional news about the application of this regulatory reliance and the benefits of priority review and how this may impact the registered certification body (RCB) and PMDA review.