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Japan Medical Device Labeling
Medical device labeling requirements in Japan are specified by the Pharmaceuticals and Medical Devices Agency (PMDA), in Artcle 52 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.
In Japan, local labeling is listed on package inserts, ‘tempu bunsho’. The package inserts should contain the information presented in the Instructions for Use (IFU) in Japanese. The Market Authorization Holder (MAH) or Manufacturer of Pharmaceuticals must affix packaging inserts as a Clearance Release Judgement requirement. Packaging inserts can be affixed in the factory of origin or done in Japan by the warehousing manufacturer. Notification is required before the medical device or IVD device can be marketed in Japan (or at the time of new approval) and when revising the package insert.
General Device Labeling Requirements
Pharmacy/Ethical drugs (not including IVD, pharmacy-compounded drugs or over-the-counter drugs), Class IV medical devices and all regenerative medical products are subject to the package insert notification system. Exemptions to be specified through ordinances of the Ministry of Health, Labor and Welfare (MHLW).
Package inserts must include:
- Date of preparation/revision
- Japan Standard Commodity Classification Number
- Therapeutic category
- Regulatory classification
- Dosage and administration
- Careful administration
- Important precautions
- Drug interactions
- Adverse reactions
- Geriatric use
- Use during pregnancy, delivery or lactation
- Pediatric use
- Effects of laboratory tests
- Precautions concerning use
- Other precautions
- Clinical studies
- Precautions for handling
- Conditions for approval
- Name and address of manufacturer or importer
- “References and request for literature should be make to:”
IVD Specific Requirements
Standards for package inserts for IVD devices are specified in Article 41-3.
IVDs are exempt from packaging requirements given:
- Package insert and other information is provided using electronic data processing systems of other information-communication technologies approved by the MHLW ordinance
- When the intended seller of an IVD device receives approval from the intended purchaser to not include a package insert
Pharmaceutical Specific Requirements
For pharmaceutical products listed in the Japanese Pharmacopoeia (JP), information specific in the JP must be included in the package insert. Marketing designated for pharmaceuticals must be immediately published using the electronic data processing system or other information-communication technologies.
Contact Asia Actual to see if our Japan labeling solutions are right for your needs.
Japan Regulatory Support
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