We handled a Chinese medical translation project involving a PMCF plan, completed under EU MDD regulations.This successful delivery impressed the client and led to more medical translation projects. Read how we handled it.
Project Overview: Post-Market Clinical Follow-Up Plan and PMCF Questionnaire
Our journey began when a medical device company approached us, seeking Chinese to English translation services for their Post-Market Clinical Follow-Up (PMCF) Plan and questionnaire for a new product.
READ MORE >> China Pharmaceutical Sector Being Regulated, Now What?
The Regulatory Landscape: EU Medical Device Regulation (MDR)
As we’re all aware, the European Medical Device Regulation 2017/745 (MDR) took effect on May 26, 2020. According to the First Clinical Journal, the MDR will significantly impact manufacturers, especially due to the high cost of implementing new regulations for new devices, as well as ensuring legacy products comply with the updated requirements.
The MDR is much stricter than the previous EU Medical Devices Directive (MDD). However, there was a transitional period of 3 years, ending on May 26, 2020, which allowed manufacturers to submit their new products under MDD, effectively postponing the mandatory MDR for a few years.
Our client wanted to submit their new product under MDD before the May 2020 deadline.
The Workflow for Chinese-to-English Medical Translation Projects
The client sent us a 6,000-word PMCF plan that had been partially translated by their staff. The original documents followed Chinese regulatory formatting and terminology, likely based on guidelines from the National Medical Products Administration (NMPA), which governs medical device approvals and documentation standards in China.
We offered a free test translation and proofreading service to ensure the client was satisfied with the quality before proceeding with the full translation.
The client was very pleased with our samples. The translator, a medical doctor based in Shanghai with a background from Newcastle University and extensive experience as a Chinese-English medical translator,worked on the Chinese medical translation project. . She also pointed out inaccuracies in some of the client’s terminology and offered valuable suggestions, which helped further improve the translation. The client felt confident in her expertise and reliability.
After the initial review, the translator completed the full translation within just two days, working even during the weekend.
Building Trust and Future Projects
The quality of our Chinese medical translation work led to future collaborations with this client, and they entrusted us with more translation projects.
🌍 The Value of Medical Translation in Regulatory Submissions
Accurate medical translation plays a pivotal role in regulatory approval—especially when dealing with technical documentation like PMCF plans, IFUs (Instructions for Use), or clinical evaluation reports. These documents must not only be linguistically accurate, but also comply with the terminology and structure expected by regulatory bodies like notified bodies or EU authorities. In this case, our team ensured that the translated PMCF plan reflected both the client’s intended meaning and the expectations of reviewers who are accustomed to a very specific scientific style.
We also provided localization support to help align drug names, device references, and expressions to standard EU medical usage. This not only reduced the risk of rejection but saved the client time and legal hassle. Thanks to our expert translator’s background in both medicine and EU regulations, we were able to bridge the cultural and technical gaps seamlessly. This is what sets professional Chinese medical translation apart from generic translation—compliance, precision, and peace of mind.
Are You Preparing for MDD Submission?
Do you have medical devices that need to be submitted under the MDD? Let us know! Our team specializes in Chinese medical translation services tailored to MDD compliancewith regulations. We are dedicated to delivering quality and timely results for your medical device needs.
