Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Cobridge Co., Ltd.
Tokyo, Japan
We assist medical device companies with the medical device registration and approval in Japan. Regulatory consulting services and DMAH services for foreign manufacturers to enter Japanese market.
MDREX, Medical Device, Digital Health Consulting Group
Seoul, Republic of Korea (HQ), Japan Office
We offer total solutions for market entry in South Korea and global expansion (e.g., Japan, USA, Europe). Key areas include product approval, reimbursement listings (HIRA), and Quality System certification (KGMP). They are particularly strong in innovative products like SaMD, medical wearables, and 3D printing for medical use, and provide in-depth expertise in cybersecurity and clinical trial planning.
CMIC Holdings Co., Ltd.
Tokyo, Japan (HQ), Osaka, Japan, Beijing, China, Seoul, South Korea, Taipei, Taiwan, Singapore, New York, USA, London, UK, Frankfurt, Germany, Sydney, Australia
We operate globally, specializing in accelerating the development, manufacturing, and commercialization of drugs and medical devices. Their expertise spans Phase I to IV clinical trials, regulatory affairs, quality assurance, and manufacturing, with a strong focus on the Japanese and Asian markets. Key services include clinical operations (CRO), manufacturing (CDMO/CMO), site management (SMO), and comprehensive health analysis and solutions.
December 6, 2025
Approximately 5 minutes
Japan Adopts Regulatory Reliance: Priority Review for US FDA-Authorized Devices
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:
- US FDA Authorization: The device must possess valid US FDA authorization (e.g., 510(k) clearance or PMA approval).
- Japanese Predicate Device: A predicate device must already be registered in Japan with the MHLW.
- 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.
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Approximately 5 minutes
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Approximately 5 minutes
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