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.
January 25, 2025
Approximately 5 minutes
Japan Medical Device Post-Market Surveillance (PMS): GVP and Adverse Event Reporting
Japan Medical Device Post-Market Surveillance (PMS)
Post-Market Surveillance (PMS) for medical devices in Japan is mandatory and heavily regulated by the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW), as stipulated in the Pharmaceutical and Medical Device Act (PMD Act).
🔑 Key Responsibilities and Compliance
The Marketing Authorization Holder (MAH) is legally responsible for all PMS activities, ensuring the continuous safety and efficacy of the device once on the market.
- Good Vigilance Practice (GVP): The MAH must establish and maintain a PMS system compliant with MHLW's Good Vigilance Practice (GVP) Ordinance. GVP outlines standards for the organization, collection, assessment, and implementation of safety measures.
- Safety Actions: Based on PMS data, the PMDA may require the MAH to implement safety measures, including:
- Product recalls and repairs.
- Revisions to the 'tempu bunsho' (package inserts/IFUs).
- Dissemination of safety information to healthcare professionals (e.g., PMDA Alerts).
🚨 Adverse Event (AE) Reporting (Fuguai)
The MAH must record and report all safety issues, commonly referred to as Fuguai (adverse events or malfunctions), via the PMDA's electronic Adverse Event Reporting System.
| Severity/Status | Reporting Deadline (from MAH awareness) |
|---|---|
| Death (Anticipated or Unanticipated) | 15 days |
| Serious, Unanticipated (Excluding Death) | 15 days |
| Serious, Anticipated (Excluding Death) | 30 days |
| Non-Serious, Unanticipated | Annual Report |
| Non-Serious, Anticipated | Unnecessary (unless incidence rate elevates) |
Reportable Events: Adverse events include device breakage/failure, malfunction, defective products, adverse health effects, and deficiencies in the provided IFU/labeling. Reports must also be submitted for adverse events occurring with Japanese-approved devices in other countries.
📝 Post-Marketing Studies and Re-evaluation
For certain high-risk or new devices, the PMDA may mandate post-marketing studies to gather real-world evidence of safety and performance. Additionally, the system includes a Re-examination and Re-evaluation process to comprehensively review approval conditions and clinical data after a set period (typically 4-10 years for drugs, though applicable concepts exist for devices).
Related Articles
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 Medical Device Registration: Pathways and Requirements
The medical device registration process in Japan is overseen by the PMDA and varies significantly based on device classification (Class I to IV). Key pathways include Pre-Market Submission (PMS), Pre-Market Certification (PMC), and Pre-Market Approval (PMA).
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 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.