Whether a product leaves China or enters it, device and machinery rules set out which language documentation must use. Four instruments that shape most technical documentation programmes:
| Market | Instrument | What it requires | What it means for enterprises |
|---|---|---|---|
| European Union | Medical Device Regulation (EU) 2017/745, Art. 10(11) | Information supplied with a device must be in the official Union language(s) determined by each Member State where it is made available. | A pan-European launch can require IFUs and labels in many of the EU's 24 official languages. |
| European Union | Machinery Regulation (EU) 2023/1230, Art. 10(7); applies from 20 January 2027 | Instructions in a language easily understood by users, as set by the Member State; digital instructions accessible for at least 10 years; paper copy free on request. | Machinery and robot documentation becomes a long-lived, multilingual compliance asset. |
| United States | FDA, 21 CFR 801.15(c) | Required label and labeling statements must appear in English, with limited exceptions. | Technical files from non-English-speaking manufacturers need submission-ready English, not merely readable English. |
| China | Provisions for Instructions and Labels of Medical Devices (CFDA Decree No. 6, 2014), Art. 9 | Text in medical device instructions and labels shall be in Chinese and meet national language standards. | Foreign manufacturers need NMPA-ready Chinese IFUs and labels. |
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.
Acknowledged in 4 hours, quoted in 24.