Indication适应症
An indication is the approved disease, condition, or clinical situation for which a medicine, biologic, or medical device is intended to be used in a defined patient population. In product information and regulatory submissions, indications are stated in labels, summary-of-product-characteristics documents, prescribing information, clinical study reports, and advertising materials, where precise wording determines the authorized scope of use and off-label boundaries.
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
Localization teams translate indication statements in prescribing information, package inserts, clinical trial protocols, health authority submission dossiers, and promotional materials for healthcare professionals. The wording must remain aligned with approved labeling in the source market, while still meeting local regulatory terminology and plain-language requirements for patients, prescribers, and review assessors.
Translation checks
A common mistake is expanding or narrowing the indication by changing qualifiers such as 'for the treatment of' to 'for the prevention of' or omitting patient population limits. This can create off-label promotion risks, make the translated label inconsistent with the approved evidence, and trigger regulatory enforcement in the target market.
Chinese document application
Indication in context · intended-use wording
- English source
- Use only for the indication stated in the IFU.
- Chinese rendering to review
- 仅用于使用说明书中载明的适应证。
Illustrative wording only. Confirm the rendering against the actual source and approved project terminology.
Check the distinction in context
An indication should not be broadened into a general product benefit. Preserve the population, condition and usage boundaries in the approved source. If intended purpose and indication appear as distinct fields, maintain the organization’s Chinese terminology distinction.
Check the returned Chinese file
Compare the Chinese indication statement with the product description supplied as context. Identify any broader marketing wording separately rather than allowing it to replace the approved population or usage boundary in the technical text.
Prepare the connected files
Supply the approved source wording and linked product descriptions. Ask the owner to confirm any mismatch between marketing copy and the technical document.
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
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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.