Medical translation poses several unique challenges, but regulatory issues are perhaps the most difficult ones to overcome.
Most countries have strict regulations regarding pharmaceuticals, medical devices and treatment services. If your organization seeks to provide medical products or services to overseas markets, it’s a safe bet you won’t be allowed to do so in English.
Make sure you are familiar with the regulatory compliance requirements that can affect your translation and localization needs.
Medical Translation Regulations
Errors in medical translation can have serious implications for health and well-being. Consequently, this industry is highly regulated around the world.
Regulations generally dictate how the translation process is conducted and how records must be maintained, protected and transmitted. Regulatory considerations vary greatly from country to country, but most locations also dictate which types of content must be translated.
Documents meant for publication or dissemination to the public carry different regulatory requirements than those designed to educate medical practitioners, for example, or package inserts for pharmaceuticals.
Expert Consultancy Services Are Essential
Packaging and labeling requirements, regulatory submission, and approval and privacy standards are only a few of the topics you must consider. Contracting the services of a locally based consultant can mean the difference between success and literal disaster in this area.
In Japan, for example, two governmental agencies must review and approve documents related to drugs or medical devices before they are published. In much of Europe, your materials must comply with both European Union (EU) regulations as well as those of the specific country in which you plan to market.
Expertise in your specific area is also critical for your project. For example, if your business model pertains to genetics or infectious diseases, a consultant who has an anesthesiology background will be of no more help than a stranger in the street.
Human Medical Translation is Necessary
No machine translation will ever meet the intense moral and regulatory obligations for medical content. Errors could result in physical harm or even death to members of the public, opening the door for devastating liability.
Using human translators with in-depth knowledge of your industry is the only way to ensure that your materials are truly localized for the target market. Cultural and regional differences extend far beyond words and phrases. Dosing or usage instructions created in English may make no sense in another language, even after the words themselves have been reliably translated.
In many cases, medical documents require a certified translation to meet regulatory requirements. At Verbatim Solutions, we provide medical document translation and localization services in hundreds of different languages and dialects, and certified translation is one of our specialties.
We also provide on-demand interpreting services to assist you in communicating with regulatory agencies.
Contact us today to learn more. Our local subject-matter experts can provide assistance with the entire localization process, ensuring that your medical translation needs are fully met.