Japan Adopts Regulatory Reliance: Priority Review for US FDA-Authorized Devices

Japan's Ministry of Health, Labour and Welfare (MHLW) has issued Cabinet Order No. 362 of 2025, marking the first time the country's medical device regulatory framework has formally adopted a regulatory reliance pathway based on a foreign regulator's authorization. This move is designed to streamline market entry and accelerate access to new technologies.

Key Update: Priority Review via FDA Reliance

The core of the new policy is the availability of Priority Review for devices that have already been authorized by an equivalent regulator, specifically the US FDA.

This policy reflects a strategic effort to leverage the rigor of the FDA's review process to ease the burden on the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).

Mandatory Conditions for Reliance

To qualify for the accelerated Priority Review, a device must meet stringent conditions that ensure alignment with Japan's existing market and safety standards:

1. US FDA Authorization: The device must possess valid US FDA authorization (e.g., 510(k) clearance or PMA approval).
2. Japanese Predicate Device: A predicate device must already be registered in Japan with the MHLW.
3. Strict Equivalence: The device seeking priority review must meet several criteria relative to the registered Japanese predicate:
   • Same device class
   • Same JMDN Code (Japanese Medical Device Nomenclature)
   • No differences in key device properties

These conditions ensure that the device leveraging the FDA authorization fits neatly within an established and pre-approved Japanese safety profile.

Implementation Timeline

This Cabinet Order marks the official introduction of the reliance principle. Further details on the operational process and specific submission guidelines from MHLW are expected before May 1, 2026. Manufacturers should monitor these impending guidance documents for full implementation instructions.