Ministerial Ordinance on Labelling
Applicable ordinance
The labelling requirements for medical devices are set out primarily in:
- PMD Act Articles 63–65 (labelling obligations and prohibition on false labelling)
- Ministerial Ordinance on the Standards for Labelling of Medical Devices (医療機器の添付文書等の記載要領を定める省令)
- Supplementary MHLW notifications that specify the exact format and content for particular label elements and device categories
MHLW — Labelling notifications (Japanese)
Mandatory label elements for all medical devices
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 — 単回使用 must appear prominently |
| Quantity | Contents of pack |
IFU requirements
Every medical device (Class II and above; Class I devices may have reduced requirements) must be accompanied by a Japanese-language Instructions for Use (添付文書 — tenpū 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 type
MHLW has issued device category-specific labelling notifications (available on the MHLW website) for implants, sterile devices, active devices, in vitro diagnostics, and other device categories that add requirements beyond the general rules. You must verify and comply with any applicable category-specific notification for your device type.
Class I devices may have different or reduced IFU requirements depending on the specific device category and risk classification. Refer to applicable MHLW notifications for Class I device labelling and IFU exemptions.