日本醫療器材在地標籤要求：Tempu Bunsho（包裝插頁）

For SaMD (Software as a Medical Device), the "labeling" requirements have shifted to digital displays. Under the Dec 2022 MHLW revision (Order No. 128), information like e-IFU Access Code should be easily viewable on the software.

Japan is heavily harmonized with ISO via JIS T 0307. You can use standard ISO symbols for things like "Manufacturer," "Date of Manufacture," and "Expiry" without accompanying Japanese text. However, specific warnings and precautions (especially those required by the PMDA during your Shonin/Ninsho approval) must be written in Japanese. You cannot rely on symbols alone for critical safety instructions or "Contraindications."

You have both options. If your foreign factory is registered as a Foreign Manufacturer (FMR), you can apply the Japanese labels during production. However, many companies prefer to ship in "Global Packaging" (English) and have their MAH or a licensed 3PL warehouse in Japan apply the local "Over-labelling." This is often more efficient for managing Japanese-specific requirements like the MAH name, address, and the specific Japan Approval Number.

Yes, for small individual packages where a linear GS1-128 won't fit, a GS1 DataMatrix is the standard alternative in Japan. According to the MHLW "Bar Code Labeling Guide," the code must be placed on the "Unit-of-Sale" (the carton). However, for "Unit-of-Use" (the individual pouch), it is highly recommended and often required by Japanese hospitals for inventory and patient safety tracking. The code must include the GTIN, Lot Number/Serial Number, and Expiration Date.