Consistency with approval or certification particulars
Align the brand name, generic device name, intended use, specifications, components, and other relevant information with the submission.
Medical Device Labeling Requirements in Japan
Statutory labeling and package inserts for Japan cannot be prepared simply by translating overseas labels or operating instructions.
They need to reflect Japanese approval or certification particulars, statutory labeling requirements, safety information, and how the device is actually used.
On this page, “package inserts” includes electronic package inserts.
To learn how to find Japanese package inserts in PMDA's database, see How to Search Medical Device Package Inserts in Japan.
Labeling and package inserts must align with the submission
Statutory labeling and package inserts communicate approval or certification particulars and information needed for safe use to healthcare professionals.
Intended use, warnings, contraindications, precautions, and operating instructions must not conflict with the submission documents or risk management documentation.
Key items to review for Japanese labeling
Statutory labeling
Include the required information, such as the Marketing Authorization Holder (MAH), approval, certification or notification number, lot or serial number, expiration date, and storage conditions.
Warnings, contraindications, and precautions
Base the content on risk management, test results, clinical evaluation, known malfunctions, and other relevant evidence.
Operating instructions
Clearly describe preparation, operation, compatible devices, and precautions so that healthcare professionals can use the device safely.
Package inserts
Prepare the information needed for safe use, including warnings, contraindications and prohibitions, precautions, malfunctions, and adverse events.
Change control
Assess how changes to labeling or package inserts affect approved or certified particulars, QMS documentation, risk management, and products already on the market.
Roles of statutory labeling, package inserts, and IFU
Statutory labeling
Display the required information on containers, packaging, the device itself, or other applicable locations. This includes information such as the MAH, approval, certification or notification number, lot number, and expiration date.
Package inserts
Provide information needed for the appropriate and safe use of the medical device.
Instructions for use (IFU)
Explain how to use the product, including preparation, connections, operation, troubleshooting, maintenance, and disposal.
Ensure that intended use, warnings, precautions, terminology, and product specifications do not conflict across these documents.
Preparing labeling and package inserts for Japan
- 1
Gather overseas documents and supporting materials
Review the latest labels, operating instructions, risk management documentation, test reports, clinical evaluation, and other relevant materials.
- 2
Compare them with the Japanese submission
Check intended use, specifications, components, warnings, performance, and other particulars against the Japanese submission.
- 3
Incorporate Japan-specific requirements
Address statutory labeling, MAH information, Japanese wording, and precautions for the Japanese market.
- 4
Check clarity for healthcare professionals
Review terminology, illustrations, operating steps, units, and references to make sure the information can be understood without ambiguity.
- 5
Reflect the approval or certification particulars in the final documents
Incorporate the particulars finalized during review or certification into labeling and package inserts.
- 6
Establish revision procedures
Define how to handle safety information, revision history, products already on the market, and communication with distributors.
Additional checks for gastrointestinal endoscopy and biliary-pancreatic devices
For ERCP devices, guidewires, cannulas, stone retrieval baskets, balloons, and biliary or pancreatic stents, the clinical workflow and compatibility with other devices are important.
- Are the intended procedure, anatomical site, and intended use clear?
- Is compatibility, such as endoscope channel diameter and guidewire diameter, clearly specified?
- Are insertion, placement, dilation, removal, and other steps clearly described?
- Are the conditions for stopping the procedure stated?
- Are risks such as migration, breakage, occlusion, and perforation, and the actions to take, described?
- Are sterilization status, the prohibition on reuse, storage conditions, and expiration date consistent with the product specifications?
Common inconsistencies in labeling and package inserts
- Translating the overseas intended use without checking the Japanese submission.
- Using inconsistent warnings or terminology across submission documents, risk management, package inserts, and IFU.
- Failing to reflect the approved or certified particulars.
- Not clearly identifying compatibility with other devices.
- Using Japanese wording that is difficult for healthcare professionals to understand.
- Not defining internal revision procedures or how to address products already on the market.
Questions about statutory labeling and package inserts
Is translating overseas labels and operating instructions into Japanese sufficient?+
No. They need to be prepared in accordance with the Japanese approval or certification particulars, statutory labeling requirements, warnings, contraindications, and precautions.
Are package inserts and IFU the same?+
They serve different purposes. Package inserts present information for appropriate and safe use, while IFU explain specific operating methods and other practical instructions.
Can labeling be changed after approval or certification?+
Yes, but depending on the change, its impact on approved or certified particulars, QMS, risk management, and other relevant areas needs to be assessed.
IVD Labeling in Japan
IVDs have product-specific regulatory and labeling considerations. Their Japanese labeling and package-insert review should reflect the IVD product category, intended diagnostic use and authorized product information.
Official Sources
For official information on electronic package inserts in Japan, refer to the following PMDA source.
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