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Tips for regulatory compliance in medical device translation services

by Alma Bartram
medical device translation services

The universe is full of people with different religions, cultures, and norms. However, regardless of whatever religion, culture or race they may be from, all humans face somewhat the same health concerns. 

As people living in different parts of the world are struggling with more or less the same illness and diseases, it is important to share discoveries in medical sciences, may they be pharma related or on the technical side of things.

In the healthcare industry, medical language translation services play a crucial role and help in effective communication with patients especially, for those who understand different languages. 

These services are used to translate medical documents so that people get proper information about the necessary care and prescribed treatment in their native languages.

What are medical devices?

These are life-saving devices, tools, or equipment. As simple as a thermometer to a ventilator, implantable pacemaker, or an infant’s incubator. Medical devices should comply with the defined rules and regulations before they reach the market or hospitals.

Importance of translation for medical devices

Medical translation is very important and helps healthcare professionals in providing treatment to patients who understand different languages. It is one of the most complex translations considering the sensitive nature of the content.

 Here are some important features of translating medical devices.

  • It ensures the access of the patient to accurate medical treatment
  • Companies expand their market reach
  • Improve patient outcomes
  • Help healthcare professionals to communicate with patients and vice versa.
  • Reduce medical errors and life threats
  •  Improve satisfaction of patients
  • Important for clinical research

Which medical device documents need translation?

Here are some medical device documents that need translation, therefore, depending on the type of product.

  •       Product Catalogs
  •       Regulatory compliance
  •       Product description
  •       Packaging labels and leaflets
  •       Patents
  •       Instruction for use
  •       Manuals and descriptions

These all documents need translation by professional companies that are providing translation services for medical documents

Inaccurate translations are one of the leading causes for medical errors. It is a matter of life and death, because, if instructions for the use of the medical device are not provided in the required language of the user it may cause life-threatening repercussions .

Tips for the regulatory compliance

Medicine boxes have different types of information about the medicines in question including their frequency of use, storage instructions, dosage forms, warnings, and side effects.

Often, this information is provided in more than one language. So, drugs and devices are highly regulated before their distribution across borders by translating packages and labels into other languages.

In this process of regulation, manufacturers choose the best medical translation services, to provide information to users in their native languages. 

English language labels are not accepted in foreign countries

There is a rule of law in the European Union. They translate the drug information, labels, or other medical device documents into the language of the country where they sell their product. However, they ensure that people in various countries understand the instructions, provided for the use of the products. In short, only English-language translation is not accepted in foreign countries.

Hiring an international regulatory consultant

A consultant who can ensure compliance with medical devices, and is familiar with regulatory translation issues, can provide the best guidelines to the translator. Medical companies must meet the regulatory requirement for selling their product.

In this way, medical companies hire international regulatory consultants from companies that provide good regulatory translation services. Because they are familiar with the labeling and packaging regulations in different countries. These translators ensure that they provide complete and accurate services.

Forbid the use of a canned machine translation program

Sometimes machines cause errors in the translation process . Also, machines may fail to translate medical terminologies. Therefore, it is important to forbid the use of the machine and work with professionals who have experience in the translation of medical documents and have knowledge of medical terminologies.

Develop region-specific labels

Now medical and pharmaceutical companies are developing labels and instructions specific to the regions, instead of providing information in all languages in a single leaflet.

Things to keep in mind while medical device translations are: instructions must be clear and concise, authentic medical writing techniques, expert human translators in the medical field, and update knowledge about medical device regulations.



Regularity guidelines are set by the health authorities for medical device translation. It ensures the safety and effectiveness of medical devices. To reach an international audience it is important to translate the medical documents. Manufacturers focus on the quality and precision of medical device translation, therefore, expanding their reach to an international market by using professional translation services.

In addition, accurate translation is important so that users understand the risks and benefits of the products. Regulation policies for medical equipment change from one country to another. There is a need to update the regulatory procedures and policies regularly in the country to ensure the effectiveness of medical devices.

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