Prepare a medical-device risk file for Chinese translation: link hazards, controls, evidence and revisions without changing the source assessment.
View the file review example ↓View references (1) ↓Keep the risk file tied to its selected source revision
A medical-device risk file translated into Chinese needs a defined source set. Identify the main assessment, its revision and the control or evidence records supplied with it. A Chinese reviewer should be able to follow the source references without guessing which attachment belongs to the assessment.
Keep standard names and editions as cited in the source, including any ISO 14971 references it contains. A request to translate an older file is different from a request to update its technical content. The document owner should identify which source issue controls the Chinese translation.
Link assessment wording, controls and evidence
Use a reference register to keep the source row, control statement and cited record together. The invented example on this page links DEMO-H-01, DEMO-C-01 and DEMO-E-01. It contains no real hazard evaluation, product setting or risk-acceptance decision.
Translate the stated assessment and rationale without silently changing its values or conclusions. If a control name differs between the main file and a supplied procedure, record both locations and ask the technical owner to resolve the source. A language reviewer should not make a new risk decision to create a smoother sentence.
From reading to a project
Follow the assessment-to-evidence references
Risk Files into Chinese · illustrative file map
- Hazard reference
- DEMO-H-01 → source row 7
- Control reference
- DEMO-C-01 → procedure revision B
- Evidence reference
- DEMO-E-01 → verification record
- Chinese review question
- Does the cited procedure use the approved Chinese control name?
Review status: questions to confirm
Keep the assessment unchanged
Translate the stated severity, probability and acceptance rationale as written. A translator should return an inconsistency as a query rather than repair the assessment silently.
Link the evidence
Check every control and test reference against the supplied file inventory. Missing annexes and superseded procedure names belong on the query sheet.
Separate decisions
Identify the technical owner who can confirm source ambiguities. Translation review and the decision to accept a residual risk are different responsibilities.
Related published experience
NIPRO Medical (Hefei)Chinese → English
Medical-device registration files and technical specifications, in volume.
The NIPRO case is separate Chinese-to-English medical-device documentation. The anonymous retained English-to-Chinese risk-file pair described in this guide is different evidence.
Supply the risk file, its revision, referenced procedures or permitted extracts, preferred terms and the required review format. Identify which linked files are in scope.
Separate the Chinese review from the technical decision
Define the requested return: an editable Chinese file, a bilingual comparison, terminology decisions or a list of open source questions. Identify who can confirm technical ambiguities and who reviews the Chinese wording. Additional specialist review or reports belong in the agreed project scope.
For repeat work, identify changed rows and newly cited records. Supply the previous approved Chinese version if it is to be reused. A translation update does not establish that the underlying assessment has been accepted, or that the product meets a regulatory requirement.
What the retained file pair supports
A retained 2018 archive pairs an English risk-management PDF with a corresponding Chinese review Word file. Matching document references and revisions support that language direction and file category. The archive does not establish final customer approval, regulatory acceptance or a newly performed risk assessment.
The separately published NIPRO Medical case concerns Chinese-to-English medical-device documentation. It is related sector experience, not the anonymous risk-file project. For instructions supplied with a product, use the IFU review guide; use this page for the linked assessment-and-evidence file set.
Questions
Which supporting files belong in a Chinese risk-file translation brief?
Can translation correct a risk score or acceptance rationale?
Who confirms technical ambiguities in the Chinese risk-file review?
Sources
- NIPRO Medical: separate Chinese-to-English sector experienceRelated published experience only. The article distinguishes it from the document example and any anonymous archived record.