Language Translation – What is regulatory translation?

Basically, regulatory translation is where legal, technical and medical translations meet.

Logically, you might think the term “regulatory translation” refers to translating rules and regulations.

In fact, the expression is more closely linked to the medical translation field.

While a great deal of medical translation involves patient-oriented medical documentation, or medical research papers, the field of regulatory translation focuses on texts used for the approval of medical devices and pharmaceutical products for foreign markets.

It is thus a very specific field where medical terminology combines with legal, technical, and even corporate language.

Documents subject to regulatory translation include:

            - Manufacturing procedures for medical devices

            - Specifications for making pharmaceuticals

            - Documents needed for clinical trials, such as informed consent forms

            - Instructions for the use of medical devices

Translating this type of document is a true niche, as translators must master all the specialized language necessary, as well as have a strong knowledge of device and drug approval processes in the target countries.

At Language Translation Inc., one of our specialties is medical translation, including the above documents and many more. We offer medical translation services in more than 40 languages.

Betty Carlson

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