Notified Body公告机构
A notified body is an organization designated by a national authority to assess whether certain products meet the requirements of applicable legislation before they can be placed on the market or bear a conformity mark. In translation and localization, it appears in conformity assessment procedures, technical file submissions, audit correspondence, and declarations of conformity for medical devices and in vitro diagnostics.
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
Notified body references appear in CE marking documentation, technical file checklists, audit reports, certificates, and correspondence with manufacturers. Translators must keep the body’s name and identification number unchanged, and they must distinguish the notified body from the manufacturer, authorized representative, importer, and regulatory authority, especially in EU texts.
Translation checks
A common error is translating “notified body” as “regulatory authority” or “competent authority,” which confuses the conformity assessment role with market surveillance or public-health oversight. That can misstate who issued a certificate or reviewed a technical file, creating compliance and liability confusion in official documents and audit trails.
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.