Medical Translation in Chinese Requires a Higher Level of Skillsets from Professional Translators
In this post, we’ll walk you through how we managed a medical translation project that led to long-term partnerships and more projects in the future.
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.
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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 Medical Translation
The client sent us a 6,000-word PMCF plan that had been partially translated by their staff. While the terms were helpful, many expressions were awkward and needed revision. We reviewed the workload and found that there were approximately 5,200 Chinese characters for translation and 800 English words requiring proofreading and rewriting.
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 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 work led to future collaborations with this client, and they entrusted us with more translation projects.
Are You Preparing for MDD Submission?
Do you have medical devices that need to be submitted under the MDD? Let us know! Our team is ready and eager to provide expert translation services to ensure your compliance with regulations. We are dedicated to delivering quality and timely results for your medical device needs.
