Medical translation in Chinese requires a very different level of expertise than general translation. The smallest mistake can compromise patient safety, cause regulatory delays, or even invalidate an entire product submission.
In this case study, I’d like to share how we handled a high-stakes medical translation project — and how it led to long-term collaboration with the client.
đź“Ś The Project
A medical device company contacted us for a Chinese-to-English translation of their Post-Market Clinical Follow-Up (PMCF) Plan and questionnaire. They were preparing critical documentation for submission under the older Medical Devices Directive (MDD) — just before the enforcement of the new MDR (Medical Device Regulation) took full effect.
đź“š Why Timing Mattered
The European Medical Device Regulation (MDR 2017/745) became fully applicable on May 26, 2020. It replaced MDD and introduced much stricter compliance requirements. Unlike previous systems, MDR does not allow grandfathering of older products — even those previously approved. Manufacturers, importers, and distributors are all required to follow stricter documentation and post-market monitoring protocols.
To avoid jumping into MDR too early, our client wanted to submit their new device under MDD before the deadline. That meant they needed an accurate and fast translation of their PMCF documents — without compromising quality.
🔍 Our Workflow
The client sent us a 6,000-word PMCF Plan. About 5,200 Chinese characters needed full translation, and the remaining 800 English words required editing and rewriting. Some of the document had already been translated in-house, but many expressions were awkward and needed refining.
To make sure we were the right fit, we offered a free test translation and sample proofreading. This helped the client evaluate our quality before committing to the full project.
👩‍⚕️ The Translator
We assigned the project to one of our medical translators — a bilingual doctor based in Shanghai, who had studied for three years at Newcastle University and had several years of experience in both clinical medicine and medical translation.
She delivered high-quality work, and also pointed out inaccuracies in the client’s original terminology. Her suggestions helped clarify critical content, which impressed the client and boosted their confidence in our team.
⚡ The Result
She completed the full project — all 6,000 words — in just two days, over the weekend. The client was not only impressed with the turnaround time, but also with the clarity, precision, and professionalism of the translation.
As a result, the client retained us for future translation work, and we’ve since completed several additional projects for them.
🤝 How We Can Help
If you’re preparing medical device documents for MDD or MDR submission, or simply need high-quality Chinese-English medical translation, we’re here to help. Our native-speaking translators have domain expertise and regulatory awareness — so your documents are accurate, compliant, and ready on time.
Let us know your needs, and we’ll do our best to support your success.
