ElendiLabs
For SaMD (Software as a Medical Device), the "labeling" requirements have shifted to digital displays. Under the Dec 2022 MHLW revision (Order No. 128), information like e-IFU Access Code should be easily viewable on the software.
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December 12, 2024
Approximately 5 minutes
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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Questions & Answers (4)
A
Anonymous
Guest
We use standard ISO 15223-1 symbols (e.g., the "hourglass" for expiry). Does Japan recognize these, or do we need to provide a Katakana translation of every symbol’s meaning on the label?
ElendiLabs
Japan is heavily harmonized with ISO via JIS T 0307. You can use standard ISO symbols for things like "Manufacturer," "Date of Manufacture," and "Expiry" without accompanying Japanese text. However, specific warnings and precautions (especially those required by the PMDA during your Shonin/Ninsho approval) must be written in Japanese. You cannot rely on symbols alone for critical safety instructions or "Contraindications."
A
Anonymous
Guest
Can we apply the Japanese labels and GS1 codes at our factory in Germany before shipping, or must the labelling be performed at a licensed "Warehousing Manufacturer" facility within Japan?
ElendiLabs
You have both options. If your foreign factory is registered as a Foreign Manufacturer (FMR), you can apply the Japanese labels during production. However, many companies prefer to ship in "Global Packaging" (English) and have their MAH or a licensed 3PL warehouse in Japan apply the local "Over-labelling." This is often more efficient for managing Japanese-specific requirements like the MAH name, address, and the specific Japan Approval Number.
A
Anonymous
Guest
Our surgical screws are too small for a standard GS1-128 linear barcode. Can we use a GS1 DataMatrix (2D code) instead, and must this code be on the "Unit-of-Use" sterile pouch or just the secondary carton?
ElendiLabs
Yes, for small individual packages where a linear GS1-128 won't fit, a GS1 DataMatrix is the standard alternative in Japan. According to the MHLW "Bar Code Labeling Guide," the code must be placed on the "Unit-of-Sale" (the carton). However, for "Unit-of-Use" (the individual pouch), it is highly recommended and often required by Japanese hospitals for inventory and patient safety tracking. The code must include the GTIN, Lot Number/Serial Number, and Expiration Date.
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Important Disclaimer
Anonymous
We sell a standalone AI diagnostic software via download. Since there is no physical box or pouch, how do we comply with the "Article 63-2" labelling requirements for codes and precautions?