Translate Instructions for Use into Japanese
PMDA-compliant IFU translations with three script systems for the Japanese market
Japan, with a market volume of approximately 35 billion euros, is the third-largest medical device market in the world — after the USA and China. The Japanese market is characterized by the highest quality standards, an aging society with increasing demand for medical aids, and an import share of approximately 45 percent. For European medical technology manufacturers, Japan thus offers one of the most attractive export destinations worldwide.
Market access requires complete translation of all instructions for use into the Japanese language — and this translation represents one of the most complex linguistic challenges in the entire medical device industry. Japan is the only country whose writing system combines three different character sets in a single text.
Kanji (漢字), characters adopted from Chinese, carry the main semantic meaning and are used for most medical terms. Hiragana (ひらがな) represent grammatical elements, particles, and some everyday words. Katakana (カタカナ) are used for foreign words, international technical terms, and certain scientific designations. The PMDA prescribes a mandatory spelling for many medical terms — violation of these conventions can jeopardize approval.
The PMDA (Pharmaceuticals and Medical Devices Agency) regulates the Japanese medical device market with its own standards that differ from the European MDR. Instructions for use must comply with JIS standards (Japanese Industrial Standards) and use PMDA-specific classification terminology. Additionally, strict formatting requirements apply to layout, font sizes, and the arrangement of safety information.
manualworks provides an end-to-end solution for Japanese IFU translations: the platform stores the correct writing system assignment for every technical term, integrates PMDA nomenclature and JIS references, and validates compliance with all formal and linguistic requirements. This gives manufacturers PMDA-compliant instructions for use that meet the high expectations of the Japanese market in every respect.
Frequently Asked Questions
Why is Japanese one of the most demanding languages for IFU translations?+
Japanese uses three different writing systems simultaneously: Kanji (Chinese characters), Hiragana, and Katakana. In medical texts, translators must decide for each term which writing system and spelling is correct per PMDA conventions. Additionally, Japanese has complex politeness levels (Keigo) whose correct application in professional documentation is essential. manualworks supports this complexity through specialized Japanese terminology and style rules.
What requirements does the PMDA impose on IFU translations?+
The PMDA (Pharmaceuticals and Medical Devices Agency) requires complete Japanese instructions for use that comply with JIS standards (Japanese Industrial Standards). Documentation must use PMDA classification and adhere to specific formatting requirements, including correct use of writing systems and standardized Japanese medical terminology. manualworks integrates PMDA specifications and JIS references into the translation process.