Editorial review: 2026-10-11 · Confirm the current official text for your product.
European Union · 01Medical Device Regulation (EU) 2017/745, Art. 10(11)
- Language obligation
- Information supplied with a device must be in the official Union language(s) determined by each Member State where it is made available.
- Confirm before translating
- Confirm destination countries, document type and intended users. There is no single language count for every EU launch.
Read official source ↗European Union · 02Machinery Regulation (EU) 2023/1230, Art. 10(7); applies from 20 January 2027
- Language obligation
- Instructions must be understandable in the language set by the Member State. Digital access and paper-copy conditions apply under Article 10(7).
- Confirm before translating
- Main application is 20 January 2027, with transitions and some earlier provisions. Digital instructions remain online for the expected lifetime and at least 10 years after market placement. A paper copy requested at purchase is free within one month; essential safety information for non-professional users must be on paper.
Read official source ↗United States · 03FDA, 21 CFR 801.15(c)
- Language obligation
- Required label and labeling statements must appear in English, with limited exceptions.
- Confirm before translating
- This provision concerns device labels and labeling, including permitted symbols and limited territorial exceptions. It does not establish the language requirements for every FDA submission; confirm the actual submission route separately.
Read official source ↗China · 04Provisions for Instructions and Labels of Medical Devices (CFDA Decree No. 6, 2014), Art. 9
- Language obligation
- Text in medical device instructions and labels shall be in Chinese and meet national language standards.
- Confirm before translating
- Use Chinese instructions and labels; Chinese governs when other languages are added. Registration and filing dossiers have separate requirements, including SAMR Order No. 47 Article 17.
Read official source ↗ Bring four details to the scope discussion
- ProductModel and intended use
- MarketDestination and release date
- DocumentsLabels, instructions or dossier
- ReadersUsers, reviewers or authorities
Prepare your project brief →Common scope questions
Does an EU launch always require 24 languages?
No. Confirm the destination countries, the document and the intended users. The EU MDR leaves the relevant official Union languages to each Member State; other documents can follow different rules.
Does 21 CFR 801.15 set the language for all FDA submissions?
No. It addresses device labels and labeling. The requirements for a submission depend on the applicable FDA route and document type. Confirm those separately before preparing the translation.
Does a completed translation establish regulatory acceptance?
No. Translation, technical review, conformity assessment and authority acceptance are separate decisions. Agree the source version, language scope, review depth and acceptance criteria for the commissioned work.
Sources: EUR-Lex, Regulation (EU) 2017/745 and 2023/1230; eCFR, 21 CFR 801.15; NMPA, CFDA Decree No. 6. Summary for orientation only; not legal advice. Check the current official text and the competent authority before relying on it.