Significance of Regulatory Translation in Life Sciences

If you are in the business of life sciences and want to expand your medical and life sciences products outside the borders then you must take the assistance of regulatory translation. These translations help to immerse in foreign markets. Companies that are dealing with life-saving medicines and devices are globalizing their services to provide the best health care services to humanity.

Do you know that every country has its regulatory policies that keep on evolving with the changes in the submission process and regulatory monitoring requirements? For this reason, you must hire a professional translation agency. These agencies have a team of linguists that are subject-matter-expert in the medical field. Therefore, they know the regulatory practices and provide you with regulatory translation services at a fast turnaround time and affordable rates and make your presence in global markets easier.

Consistency in Translations

Life science is one of the foremost regulated industries of the world. Mis-translation and errors in translation can put human life at stake. Therefore, the medical regulatory document’s translation must be precise and up to the mark. In some developing countries where regulations are not followed, certain drugs are sold that are forbidden in developed countries. If information about such medicines and devices is provided to the health service providers in the language that they understand then illegal selling of these products and services can be prohibited.

To lower the risks and impacts of globalization, stringent quality control guidelines are followed in medical regulatory document translation. It involves different parts of translation like formatting, style, glossaries, and using voice during the translation of STDs/CTDs and EHRs. The one important thing to keep in mind in these translations is to understand which languages are required by regulatory authorities so that they can make them applicable. Abiding by the regulatory rules is called compliance. People can understand the regulatory rules if they are provided to them in the language that they understand. Here first you require regulatory materials translation and to make them applicable you must take the assistance of regulatory compliance translation.

The US Food and Drug Administration FDA requires translation in the English language only. On the contrary, European Medicines Agency EMA requires regulatory affairs translation services in 24 languages. In addition to it, the National Medical Products Agency wants Chinese translation with proper formatting layout, margins, and the required file type. This is important to get regulatory compliance and approval.

Process of Translation

In the translation process, some languages expand while others contract. Therefore, it needs to be examined carefully if you are submitting a compliance translation. For instance, if you want to submit to Japan’s regulatory body then Medical Devices Agency requires documents in the Japanese language. For translating the document from English to Japanese, understanding the difference between the two languages is extremely important. This is because Japanese characters are larger than English characters, and consume a lot of space. Therefore, it becomes difficult to accommodate the letters in the required language. It makes it even more complex when Japanese is translated to English because of the contraction issue. These things should be considered before preparing the document for compliance purposes.


Translation Regulations for Medical Devices

Medical devices are the great invention of life sciences. The worth of the medical device business is €95 billion in European Union only. Therefore, to get leverage from the medical device market, the medical device companies should take into consideration the requirements of all relevant target markets. Each country has its standards and its own regulatory body.

Translation requirement depends upon the target market and the type of device. The regulatory translation should not be limited to marketing material only. They should also consider the interface for the device and how to make instructions user-friendly for the user. Sometimes device user interfaces need to be modified to accommodate local scripts.  Translation of the medical device depends upon the language that the target market speaks. In the EU the marketing material is available in 24 official and spoken languages of the member states. In other countries, it is required to translate the content into the official language only or any one of the minority languages.

Medical devices also vary according to the risk they can put on human life. For this reason, the requirement of each device translation is different. For instance, currently, the EU has segregated medical devices into four categories according to their risk factor. Target market is another factor in some countries like the United Kingdom, Ireland, Luxembourg Poland, and Malta. These countries want medical device labeling translation in English only if the device is recommended to be used by professionals only. Translation and labeling of the device for medical professionals will mitigate the probabilities of injuries caused by translation services.

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