Ministerial Ordinance on Labelling
Applicable ordinanceโ
The labelling requirements for medical devices are set out primarily in:
- PMD Act Articles 63โ65 (labelling obligations and prohibition on false labelling)
- Ministerial Ordinance on the Standards for Labelling of Medical Devices (ๅป็ๆฉๅจใฎๆทปไปๆๆธ็ญใฎ่จ่ผ่ฆ้ ใๅฎใใ็ไปค)
- Supplementary MHLW notifications that specify the exact format and content for particular label elements and device categories
Official source
MHLW โ Labelling notifications (Japanese)
Mandatory label elements for all medical devicesโ
Every medical device sold in Japan must carry a label in Japanese containing:
| Element | Details |
|---|---|
| Device name | The approved/certified device name as it appears in the Shonin or Ninsho |
| MAH name and principal office address | Must match the current MAH licence |
| Manufacturing number or lot number | For production traceability |
| Approval/certification number | The Shonin number or Ninsho number |
| JMDN code | Required on device label |
| Storage conditions | Required if the device requires special storage (temperature, humidity) |
| Expiry date or manufacturing date | Required for devices with a defined shelf life |
| Sterility statement | "Sterile" claim if applicable; sterilisation method if required |
| Single-use designation | If the device is single-use only โ ๅๅไฝฟ็จ must appear prominently |
| Quantity | Contents of pack |
IFU requirementsโ
Every medical device (Class II and above) must be accompanied by a Japanese-language Instructions for Use (ๆทปไปๆๆธ โ tenpลซ bunsho). The IFU must include:
- Approved intended use / indications
- Contraindications
- Warnings and precautions
- Instructions for use / operating instructions
- Maintenance and cleaning instructions
- Storage conditions
- Shelf life
- Adverse event reporting instructions (for reporting to the MAH)
The content of the IFU must not exceed the scope of the approved intended use. Claims not in the approved Shonin/Ninsho are prohibited.
Special labelling rules by device typeโ
MHLW has issued device category-specific labelling notifications for implants, sterile devices, active devices, and IVDs that add requirements beyond the general rules. Verify applicable specific notifications for your device category.