Vigilance Reporting警戒报告
Vigilance reporting is the ongoing regulatory obligation for medical device manufacturers, authorized representatives, and importers to notify competent authorities about serious incidents, deaths, or health-related events linked to a marketed device. It operates within post-market surveillance and generates field safety notices, periodic summary reports, adverse trend analyses, and risk management records that regulators may inspect during audits or compliance reviews.
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
Vigilance reporting content appears in adverse event narratives, field safety notices, periodic summary reports, and correspondence with competent regulatory authorities. Translators working on these submissions must preserve report categories, event dates, severity terms, and anonymized patient details so that the translated text meets the destination regulator’s format and reporting expectations.
Translation checks
A frequent error is translating “vigilance” as if it meant passive monitoring or surveillance, which weakens the sense of a mandatory reporting duty. Underplaying that duty in a field safety notice or adverse event report can make a required submission read like an optional update, or lead to inconsistent severity classification across languages.
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 → EnglishQuality manuals, SOPs, production-process and clinical-trial documentation.
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.