A technical file is a structured compilation of technical documentation showing that a medical device conforms to the relevant regulatory requirements, particularly for CE marking under European legislation. In translation and localization, it includes device descriptions, risk management files, clinical evaluation reports, labeling, and test results, and it must be organized for regulatory assessment by notified bodies or competent authorities.
Updated
Angel Translation editorial reference · Confirm the rendering against your source and approved project terminology.
Check source meaning → confirm the preferred term → record approved variants and references.
Technical file translation is common in medical device submissions for CE marking, notified body reviews, and post-market obligations. Translators handle device descriptions, instructions for use, risk documentation, and clinical evidence, often working with templates that must be adapted to the target country without changing technical data or intended purpose.
One serious error is translating 'intended purpose' loosely, because it can change the device classification or regulatory scope. Another is inconsistency between the technical file and labeling or instructions for use. Missing or altered declarations and standards references can also trigger notified body questions, rejection, or requests for resubmission.
From reading to a project
Review status: questions to confirm
Record whether the supplied file says “Technical File” or “Technical Documentation.” Do not silently replace one English source label with the other.
Retain the file ID, revision and cited annex or section reference beside the translated index label so the Chinese entry can be traced back to the source.
Confirm the Chinese index label with the reader or termbase owner. Keep an English reference heading where needed to distinguish a source title from a cited heading; a Chinese label should preserve that source relationship.
List the exact source headings, file IDs, revisions and cross-references; confirm project Chinese labels and reviewer.
Check intended use, warnings, document versions and approved terminology with the project team. Translation supports documentation; it does not establish product approval or regulatory acceptance.
Provide approved terms and previous translations with the source files. Agree how variants, ambiguous wording and revisions will be reviewed. Terminology maintenance and any termbase handback are confirmed in the project scope. See the 8-step AI + expert workflow.
Include the source and target languages, file types, intended use, deadline and any approved termbase. Agree handling before sending sensitive files. Acknowledged in 4 hours, quoted in 24.
Prepare a Chinese technical-file inquiry →Life Science solutions →File handling →A glossary entry is not an official standard or evidence of regulatory acceptance. Confirm current requirements for your project separately.