Getting the language right isn't the hard part. Getting the context right is.
A Shanghai-based studio specializing in localization for overseas medical device companies entering China — NMPA-compliant IFU, labeling, technical and clinical documentation, where regulatory context and terminology consistency decide whether your filing moves or stalls.
Built around your China documentation.
From the IFU on the box to the clinical dossier in your submission — we handle the documentation overseas medtech companies need in Simplified Chinese, with the standardized regulatory terminology NMPA reviewers expect.
NMPA-compliant IFU & Labeling
Instructions for use, labels and packaging copy in Simplified Chinese, built to China's labeling rules and standardized regulatory terminology — the documents most likely to trigger queries when mistranslated.
Technical & Clinical Documentation
Technical files, Product Technical Requirements (PTR) and clinical data localized by senior medical translators — accurate, consistent and review-ready.
Lifecycle Terminology Management
One controlled glossary across every IFU revision — from type-testing to final certificate — so your documentation stays consistent across a 1.5–2 year registration instead of scattered across vendors.
Market-Access, Marketing & Training
Once you're in market: marketing collateral, training materials, compliance communication, and product / website localization adapted for Chinese audiences and platforms.
We don't run all content through one process.
Different content requires different handling. We tier every project by sensitivity — so you get the right level of care for each piece, with strict safeguards on confidential work.
Marketing & training content
Efficient, AI-assisted workflows reviewed by senior bilingual editors — fast and consistent for non-confidential material.
Regulatory, clinical & confidential documents
IFU, technical files and clinical data handled from scratch by senior medical translators.
Every project — regardless of tier
Gets a final review by the founder before delivery. One person owns the quality of what leaves the studio.
A studio you can hold accountable.
Choosing a localization partner for a regulated submission is a high-trust decision. Here's why medtech teams hand us documents they can't afford to get wrong.
A decade specializing in medtech documentation, with zero client disputes on record — a clean, verifiable track record for work where patient safety and compliance are on the line.
NDA and service agreements in both languages, with a US/EU-compliant English version — so the terms protect your side too.
You talk to me, not a sales pipeline. One accountable point of contact who manages your project end to end.
New client inquiries can request a free sample translation — judge the quality first. Translators Association of China — membership application in progress.
Ten years inside medical device localization for China.
I'm Clover Song, founder of Youeson Translation (优译逊翻译), a Shanghai-based studio specializing in medical device localization for overseas companies entering the China market — with zero client disputes on record over ten years.
I work alongside your regulatory team and your China Authorized Agent: we localize your IFU, labeling, technical and clinical documentation into compliant, consistent Simplified Chinese — you and your agent handle the filing.
Client intake, terminology control, quality and final delivery run through one accountable person, supported by a vetted network of senior medical and technical translators. We also take on cross-border legal and business translation where China is involved.
Send us the content. We'll return a free sample.
Send us an IFU, a label, or a technical file — tell us your device and where you are in the NMPA process. New client inquiries receive a complimentary sample translation so you can judge the quality first.