Clinical trial protocols, MFDS regulatory submissions, medical device documentation, and patient materials translated by Korean medical specialists.
South Korea's Ministry of Food and Drug Safety (MFDS) is one of the most rigorous pharmaceutical and medical device regulatory authorities in Asia. Companies seeking Korean market approval must submit comprehensive Korean-language dossiers meeting MFDS-specific formatting and terminology requirements. Our Korean medical translators hold degrees in medicine, pharmacology, or biomedical sciences and are fully fluent in MFDS submission standards and K-ICH harmonization guidelines.
In-depth knowledge of MFDS drug and medical device registration requirements, including the KFDA predecessor standards that still govern some product categories.
Translation, editing by a second Korean medical linguist, and a final terminology check against MFDS-approved Korean medical glossaries.
Every Korean medical project is handled by a translator with a proven background in medicine, pharmacology, or biomedical sciences.
Documents are prepared in line with K-ICH guidelines and harmonized ICH standards applicable to Korean regulatory submissions.
“Amazing service! Very professional and quick. Greta communication via WhatsApp and email. I needed my documents very last minute and BeTranslated bent over back to help me with it, delivering hard copy too! Thank you - will use them definitely again in future.”
Google review (SL) , 9 months ago
“We regularly use BeTranslated's translation services and are very satisfied with their work. The team is professional and highly efficient! We highly recommend them.”
Google review (FR) , 2 years ago
“Reliable, trustworthy and customer-centric This is the summation of Michael, Suzy and their team of translators. I have worked with them for over a year, and they have been my translation service for advertising in many European languages - from Swedish to German to Russian, and not always from English! Consider them a rare find.”
Google review (INTL) , 6 years ago
Yes. We have experience producing Korean-language dossiers for MFDS drug registration and medical device marketing authorization, following the specific formatting and terminology requirements of the Korean regulatory authority.
Yes. We translate clinical trial documentation in line with K-ICH guidelines and the relevant ICH guidelines adopted in Korea, ensuring regulatory compliance for Korean trial sites.
We build client-specific Korean medical glossaries and translation memories at project start and maintain them throughout the full regulatory dossier lifecycle, ensuring consistency across all modules and submissions.
Yes. Korea's Ministry of Food and Drug Safety (MFDS) requires CTD format submissions following K-ICH harmonization guidelines. Our translators apply MFDS-specific terminology conventions for drug classification, adverse event nomenclature, clinical trial phasing, and device risk class categories. For pharmaceutical products we confirm whether the submission falls under the domestic bioequivalence pathway or the new drug application pathway, as these have distinct Korean documentation requirements.
All translators and project managers sign GDPR-aligned data processing agreements before receiving any patient-identifiable or trial-confidential material. For Korean projects we additionally apply the Korean Personal Information Protection Act (PIPA) handling requirements. Files are transferred over encrypted channels and purged from our systems on project closure unless you request translation memory retention.
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Send us your korean medical translation files, language pairs, and deadline. We will confirm specialist availability, certification needs, and a clear quote as quickly as possible.
