Declaration of Conformity符合性声明
In the life-science sector, a Declaration of Conformity is a formal statement issued by a manufacturer affirming that a product meets all relevant applicable regulatory requirements, standards, or directives for its intended target market. In translation and localization, this document forms part of technical files, regulatory submissions, and product documentation packages, and it often accompanies regulatory labeling or instructions for use.
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.
Where this term appears
Localization teams encounter Declarations of Conformity when translating EU or other regional technical documentation, regulatory dossiers, and product inserts. It must often remain accurate with respect to directive titles, standards references, and authorized signatory information; language service providers may also handle certified translations requested by notified bodies or importers or distributors.
Translation checks
A common error is treating the Declaration of Conformity as a certificate issued by a regulator, when it is actually a manufacturer self-declaration. Translators may also blur the distinction between directives and standards or mistranslate the authorized signatory. Such errors can cause market access delays or rejection during documentation review.
Keep the term aligned across your files
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.
Related document experience
NIPRO Medical (Hefei)
Chinese → EnglishMedical-device registration files and technical specifications, in volume.
Read the published project →
Walvax Biotechnology
Chinese → EnglishVaccine-production process documentation, SOPs, quality-control standards and microbiology-testing procedures.
Read the published project →Published scope shows related industry experience; it does not confirm that this specific term was used or reviewed in the project.
Working on life science documentation?
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 an inquiry email →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.