Medical translation is the translation of technical, regulatory, clinical or marketing documentation, software or training curriculum for the pharmaceutical, medical device or healthcare fields. Most countries around the world require that literature and labeling associated with medical devices or pharmaceuticals sold be translated into the national language(s). In addition, documents necessary to conduct clinical trials often require translation in order for local clinicians and patients and regulatory representatives to be able to read them. Regulatory approval submissions typically have to be translated as well Regulations for Medical Devices and the Role of Guidance Documents in Europe EU Medical and IVD Device Labeling: Translation Requirements and Trends.
Aside from linguistic skills, it requires specific training and subject matter knowledge in order to translate medical content. This is because of the highly technical, sensitive and regulated nature of medical texts.
Because medical translation is typically a multi-step process, it is usually carried out by a translation agency which oversees all project management and the linguistic team. Steps in the process can include:
- Extraction of text from source format
- Translation – the conversion of the source language text to the target language text
- Editing – reading and revision by a separate person to assure adherence to approved terminology and the proper style and voice.
- Publishing – the translation is put back into the original format (e.g., Word document, Web page, e-learning program)
- Proofreading – this ensures that the formatted translation displays correctly with no corrupted text, has proper punctuation and line and page breaks are correct.
- In-country review – a native-speaking expert reviews the translation to ensure that it meets all specifications and product or therapy specifics.
The international medical industry is highly regulated and companies who need to translate their documentation typically choose translation agencies that are certified or compliant with one or more of the following standards:
- ISO 9001 – quality system standard
- EN 15038 – European standard for translation vendor quality Translation-quality standards
- ISO 13485 – overarching standard for manufacture of medical devices