Post-Market Surveillance上市后监督
Post-market surveillance is the set of activities a manufacturer uses to collect, analyze, and act on safety and performance data after a medical device or product is placed on the market. In translation and localization, it appears in PMS plans, periodic safety update reports, vigilance reports, post-market clinical follow-up documentation, and regulatory submission updates that describe how the manufacturer monitors ongoing safety and performance.
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
Post-market surveillance appears in regulatory submission annexes, PMS plans, periodic safety update reports, and vigilance system documentation for medical devices and medicinal products. Translators must keep terms like “complaint,” “incident,” “serious adverse event,” and “trend” distinct, because misclassification can change reporting obligations or risk conclusions.
Translation checks
A common error is translating PMS terminology too broadly, merging “adverse event,” “incident,” and “complaint” into one word. That can erase regulatory distinctions and make reports look incomplete or inaccurate. Translating “surveillance” as “monitoring” may also be acceptable in context, but the chosen term must match the client’s quality system and local regulatory usage.
Chinese document application
Post-Market Surveillance in context · surveillance plan
- English source
- Review the information collected under the surveillance plan.
- Chinese rendering to review
- 审核按照上市后监督计划收集的信息。
Illustrative wording only. Confirm the rendering against the actual source and approved project terminology.
Check the distinction in context
A plan, an activity and its report are different records. Keep their references and review periods clear in Chinese. Do not turn a description of collected information into a claim that every issue was resolved or that a product remains approved.
Check the returned Chinese file
Compare the Chinese plan and report headings with their source periods. Preserve whether the file describes planned collection, collected information or a completed review, and retain unresolved source status in the query record.
Prepare the connected files
Provide the plan and report inventory with approved terminology. Confirm which linked documents are part of the quote and which only establish context.
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.