Prepare medical-device technical files, IFUs, SOPs and clinical documents for Chinese readers. Identify the source versions, terminology references and people who will review the Chinese wording.
Tell us what the documents are for, which source revision to use and who will read the translation.
IFU (Instructions For Use), labelling and packaging.
510(k) material, CE/MDR technical files and risk management files.
Clinical protocols, SOPs and CAPA documentation.
| Reference | Source | Translation |
|---|---|---|
| Device name | Approved name | Same reference |
| Section numbering | Source structure | Matched |
| Revision | Confirmed version | Linked record |
Warnings, section hierarchy and approved terminology remain easy to cross-check.
Published projects across medical devices, hospitals, pharmaceuticals and vaccine development. Each case identifies the actual file scope and language direction.
Walvax BiotechnologyVaccine-production process documentation, SOPs, quality-control standards and microbiology-testing procedures.
Chinese → EnglishRead project details →
NIPRO Medical (Hefei)Medical-device registration files and technical specifications, in volume.
Chinese → EnglishRead project details →Medical records and clinical documentation for international patients.
English ⇄ ChineseRead project details →
Jiangsu Xinlikang MedicalTechnical documentation for imported medical devices.
German → Chinese / EnglishRead project details →Drug-development agreements and clinical-trial documentation.
English → ChineseRead project details →
Synaptic Medical (Beijing)Multilingual technical files for cardiac-intervention devices.
MultilingualRead project details →In a regulatory submission the text is not a wrapper around the evidence — it is part of the evidence. Reviewers read what you filed. An ambiguous rendering of an indication, a contraindication or a performance claim becomes a question to answer, and questions cost review cycles.
Regulated terminology is defined by the governing standard and by your own device labelling. A defensible synonym is still the wrong word if the standard and your label use another. Consistency with the source document set matters as much as linguistic quality.
A quality system requires a documented process with accountable steps. Text of unclear provenance — including unreviewed machine output — is difficult to defend during an audit, regardless of whether it happens to be correct.
Member states determine the language(s) required for IFU and labelling in their market. Requirements are per-market, not EU-wide.
Filed in English. Where source documentation, clinical data or QMS records were authored in another language, accurate English rendering is required.
A documented, auditable translation process with defined review steps.
Compare the preparation guide and the recorded project scope, then tell us which files you need in Chinese. Select your actual source language in the inquiry form.
List device models, source revisions and technical questions for the Chinese document set.
Preparation guide →Jiangsu Xinlikang Medical →German-to-Chinese / English imported medical-device technical documentation.
Keep study identifiers, source versions and review responsibilities visible.
Preparation guide →English-to-Chinese drug-development agreements and clinical-trial documentation.
Confirm the record inventory, legibility and intended recipient before sharing sensitive material.
Preparation guide →English–Chinese medical records and clinical documentation.
Start with the intended use, the document list and source revisions. Record approved Chinese product names and terminology, and list unresolved translation questions separately.
Use the China document preparation tool above to organize this information. For market-specific research, see medical device regulatory research for China →. Research and translation scopes are agreed separately; a document register does not establish regulatory compliance or approval. It is not an FDA or MDR submission template.
For a quote, include the source files, language direction, intended use and required date. Discuss your project →
Selected bilingual references. The full terminology glossary remains available below.
“Documentation submitted to Europe for review is held to a very high standard. Angel recommended using English as the source language and having native-speaker translators handle it — the result met our expectations, and they were willing to take our experts’ feedback and revise patiently.”
Acknowledged in 4 hours, quoted in 24. Discuss confidentiality before sharing sensitive files.