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.
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.
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.
Chinese document application
Vigilance Reporting in context · vigilance procedure
- English source
- Follow the reporting route defined in the procedure.
- Chinese rendering to review
- 遵循程序中规定的报告路径。
Illustrative wording only. Confirm the rendering against the actual source and approved project terminology.
Check the distinction in context
Keep the report type, responsible role and referenced procedure intact. Market-specific reporting conditions and deadlines require the responsible owner’s confirmation. The translation should convey the supplied procedure rather than generate a new reporting rule from the term alone.
Check the returned Chinese file
Follow a role reference in the Chinese procedure to the corresponding reporting form. Check that responsibilities stay attached to the correct step and that translated wording has not created a new external reporting obligation.
Prepare the connected files
Send the procedure revision and reporting-form labels. Ask the owner to resolve inconsistent roles or source references before the Chinese text is finalized.
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)
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Read the published project →
Walvax Biotechnology
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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.