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.
November 25, 2024
Approximately 5 minutes
Japan Medical Device Registration: Pathways and Requirements
Overview of Japanese Medical Device Registration
Medical device registration in Japan is governed by the Pharmaceutical and Medical Device Law (PMDL) and overseen by the Pharmaceuticals and Medical Devices Agency (PMDA) of the Ministry of Health, Labor and Welfare (MHLW). The process complexity, cost, and timeline depend heavily on the device's classification and whether a predicate device exists.
Device Classification
Devices are classified into four risk categories:
- Class I: Low Risk
- Class II: Medium Risk
- Class III: High Risk
- Class IV: Highest Risk
Classification uses the Japan Medical Device Nomenclature Code (JMDN code) system.
Key Requirement: The DMAH
Foreign manufacturers must appoint a local entity known as the Designated Market Authorization Holder (DMAH). The DMAH is responsible for:
- Submitting all applications to the PMDA.
- Holding the device license.
- Communicating with the PMDA.
Registration Pathways
Japan utilizes three primary pathways for market entry:
-
Pre-Market Submission (PMS) / Todokede
- Applicable Devices: Low Risk Class I devices.
- Process: Applications are submitted to the PMDA and considered accepted upon submission.
- Timeline: Approximately one week for a PMS number.
- Cost: No PMDA fee.
-
Pre-Market Certification (PMC) / Ninsho
- Applicable Devices: Most Class II and certain generic Class III devices with established specifications (AS/predicates).
- Process: Review and Quality Management System (QMS) conformity assessments are outsourced to Registered Certification Bodies (RCBs).
- Timeline: Average of 3 months.
- Cost: Average around US$30,000 for the review.
-
Pre-Market Approval (PMA) / Shonin
- Applicable Devices: New devices across Class II, Class III, and Class IV.
- Process: Reviewed directly by the PMDA. This pathway is required for "new," "improved," or non-generic devices, especially those lacking applicable JMDN codes or predicates.
- Timeline: Varies widely, from 6 months to 36 months, depending on the need for local clinical evidence.
- Cost: Varies from US$20,000 to US$120,000.
Quality Management System (QMS)
While ISO 13485 is not mandatory, manufacturers must comply with Japan's local Good Distribution Practice (GDP) requirements, as stipulated in MHLW Ministerial Ordinance No. 169 (2004).
License and Importation
- License Validity: Medical device licenses in Japan do not expire.
- Importation: The DMAH can authorize multiple importers to import products under a single license.
Related Articles
Approximately 5 minutes
Japan Medical Device Local Labeling Requirements: Tempu Bunsho
Medical device labeling in Japan, specified by PMDA's Article 52, mandates the use of Japanese 'tempu bunsho' (package inserts/IFUs). This process involves rigorous content requirements, notification upon revision, and MAH/DMAH oversight for affixation.
Approximately 5 minutes
Japan Medical Device Post-Market Surveillance (PMS): GVP and Adverse Event Reporting
An overview of Japan's PMS requirements under the PMD Act, focusing on the MAH's GVP compliance, the mandatory reporting of adverse events (Fuguai), and the strict reporting timelines (e.g., 15 days for death or serious, unanticipated events).
Approximately 5 minutes
Japan Specialty Fulfillment for Medical Devices: Low Volume, High Value Sales
Specialty Fulfillment is a crucial service for foreign medical device manufacturers targeting low-volume, high-value sales in Japan, often utilizing an Independent License Holder to manage customs, storage, and distribution to maintain high profit margins.
Approximately 5 minutes
Japan Adopts Regulatory Reliance: Priority Review for US FDA-Authorized Devices
Japan’s **MHLW** has introduced a major policy shift (Cabinet Order No. 362 of 2025) allowing **Priority Review** for medical devices that already hold **US FDA authorization**. This reliance aims to accelerate market access, but strict conditions apply concerning the device class, **JMDN Code**, and key properties matching an existing Japanese predicate device.