Japanese Labelling Requirements
Japanese labelling requirements are specified in the PMD Act (Article 63 onwards) and the associated Ministerial Ordinance on Labelling. Most mandatory label elements must appear in Japanese. The requirements differ meaningfully from EU MDR labelling symbols and FDA labelling regulations.
Mandatory label elements
All medical devices placed on the Japanese market must have labels that include the following in Japanese:
| Element | Notes |
|---|---|
| Device name | The approved/certified device name |
| MAH name and address | The Japan-domiciled MAH; not the foreign manufacturer's name |
| Approval or certification number | Shonin or Ninsho number — must appear on label |
| JMDN code | Required on label |
| Manufacturing date or expiry date | Format: YYYY/MM or as specified |
| Lot number or serial number | For traceability |
| Storage conditions | If special conditions apply |
| Sterility statement | If the device is supplied sterile |
| Quantity per pack | |
| Warnings and precautions | Key safety information in Japanese |
| Single-use symbol or reuse statement | 単回使用 (single use) or reuse instructions |
MAH name and address — not the foreign manufacturer
A notable difference from EU MDR: Japanese labels must show the MAH's name and address, not the manufacturer's name as the primary identification. The manufacturer's name may also appear, but the MAH is the legally identified entity on the label.
For overseas manufacturers, this means the label will show a Japanese company name (the MAH), which may be unfamiliar to non-Japanese stakeholders.
JMDN code on label
Including the JMDN code on the device label is a Japan-specific requirement. The JMDN code is used by healthcare institutions for procurement, traceability, and insurance reimbursement purposes.
Unique Device Identification (UDI) in Japan
Japan is developing its UDI system aligned with the IMDRF UDI guidance. MHLW has published phased implementation timelines for UDI application by device class. Check current MHLW guidance for the latest UDI implementation deadlines applicable to your device class.
Languages
All mandatory label elements must appear in Japanese. Additional languages (English, Chinese, etc.) may also appear on the label. Where the Japanese and any other language text differ, the Japanese text is the operative version.