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 12, 2024
Approximately 5 minutes
Japan Medical Device Local Labeling Requirements: Tempu Bunsho
Japan Medical Device Labeling: The Tempu Bunsho
Local labeling for medical devices in Japan is a critical regulatory step governed by the Pharmaceuticals and Medical Devices Agency (PMDA), primarily through Article 52 of the Act on Securing Quality, Efficacy and Safety of Products. The core requirement centers on the package insert, known locally as 'tempu bunsho'.
Key Requirements
- Language: The 'tempu bunsho' must contain the full Instructions for Use (IFU) information, entirely presented in Japanese.
- Applicability: The package insert notification system applies to Class IV medical devices and certain pharmaceutical/regenerative medical products. Exemptions are possible via MHLW ordinances.
- Affixation Responsibility: The Market Authorization Holder (MAH) or Manufacturer of Pharmaceuticals must ensure the package inserts are affixed to the product as a Clearance Release Judgement requirement. This affixation can occur either at the factory of origin or in Japan by the warehousing manufacturer.
- Notification: Notification to the PMDA is mandatory before the device is marketed (or at the time of new approval) and whenever the package insert is revised.
Required Package Insert Content
The 'tempu bunsho' must include extensive and detailed information, generally covering:
- Date of preparation/revision
- Japan Standard Commodity Classification Number
- Therapeutic category and Regulatory classification
- Name and description of the device
- Warnings and Contraindications
- Indications and Dosage and administration
- Detailed precautions (including drug interactions, adverse reactions, geriatric/pediatric use, etc.)
- Pharmacokinetics, Clinical studies, and Pharmacology
- Precautions for handling
- Name and address of manufacturer or importer
IVD Specific Requirements
In-Vitro Diagnostic (IVD) devices have specific standards outlined in Article 41-3. IVDs may be exempt from the requirement for a physical package insert if:
- The information is provided using electronic data processing systems or other MHLW-approved communication technologies (e-IFU).
- The intended seller of the IVD receives approval from the intended purchaser to not include a package insert.
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Approximately 5 minutes
Japan Medical Device Post-Market Surveillance (PMS): GVP and Adverse Event Reporting
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Approximately 5 minutes
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Approximately 5 minutes
Japan Medical Device Registration: Pathways and Requirements
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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.