Worldwide Language Requirements for Medical Device Translations

There are nearly as many requirements for medical device translations as there are countries in the world. We’ve invited Karla Haynes of Global Simple, LLC to shed some light on what you can expect when it’s time to go global.

When considering your language requirements for medical device translations, you’ll need to consider two different categories of translations – submission documents and labeling documents. Submission documents are provided to the regulatory agency governing the sale and licensing of medical devices, while labeling documents are applied directly to the product or govern the use of the product in the field. In many cases, the language requirements for submission documents and labeling documents are the same, but some countries will accept submission documentation in other languages. These exceptions for the major markets are covered below (some smaller markets with low ROI have been omitted from this analysis.) ^[1] There are also 64 countries without a regulatory agency governing the registration of medical devices. ^[2] These are not covered in this article.

The Americas and the Caribbean 

The Americas can be covered with four languages – English, French (Canadian), Portuguese (Brazilian) and Spanish. For these countries, both the submission documents and the labeling documents must be in the languages indicated below:

English – United States, Canada (submission for Canada may be in English, but labeling documents must also be provided in French), Jamaica, and Trinidad

French – Canada (submission for Canada may be in French, but labeling documents must also be provided in English)

Portuguese (Brazilian) – Brazil

Spanish – Argentina, Bolivia, Chile, Colombia, Costa Rica, Cuba, Ecuador, El Salvador, Guatemala, Guyana, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Uruguay, Venezuela

Europe (EU members)

Countries that are part of the EU are required to provide submissions in just one of the member state languages listed below (as agreed with their notified body) in order to take advantage of trade agreements. However, labeling documents must be submitted for at least one of the member state languages per country listed below to be allowed on the market in the EU. Many of these languages can also be used for smaller countries throughout Africa and Oceania.

Croatian – Croatia

Czech – Czech Republic

Danish – Denmark

Dutch – Belgium, Netherlands

English – Ireland, Malta

Estonian – Estonia

Finnish – Finland

French – Belgium, France, Luxembourg

German – Austria, Belgium, Germany, Luxembourg

Greek – Greece, Cyprus

Hungarian – Hungary

Italian – Italy

Latvian – Latvia

Lithuanian – Lithuania

Luxembourgish – Luxembourg (Luxembourg also accepts German and French)

Maltese – Malta (Malta also accepts English)

Polish – Poland

Portuguese (European) – Portugal

Romanian – Romania

Slovak – Slovakia

Slovenian – Slovenia

Spain – Spanish

Swedish – Finland, Sweden

Turkish – Cyprus

Europe (non-EU members)

Countries that are not part of the EU are regulated separately.  However, many companies find that there may be some advantage to adding these languages to the labeling for the EU in order to take advantage of trade agreements or EU MDR equivalency.

English – Serbia (submission only), United Kingdom

Russian – Belarus, Russia

Icelandic – Iceland

German – Liechtenstein

French – Monaco, Switzerland

Norwegian – Norway

Turkish – Turkey

Ukrainian – Ukraine

Asia, South Asia, and Oceania 

Asia, South Asia, and Oceania in many cases require a local presence in order to work with the local bodies to meet the unique language needs. For example, many medical device companies have a presence in both Japan and China to not only manage translated content, but to create unique content just for those regions.

English – Australia, India, Malaysia, New Zealand, Singapore, Taiwan (submission documents)

Chinese (Simplified) – China

Chinese (Traditional) – Taiwan (labeling documents)

Japanese – Japan

Korean – South Korea, North Korea

Middle East/Africa

The Middle East and Africa are largely covered with English content for submissions and labeling.  Some devices indicated for home use require the addition of Hebrew and Arabic language for labeling only.  The main exceptions are those countries that require French documentation.

English – Egypt, Ghana, Israel, Kenya, Namibia, Nigeria, Saudi Arabia, Sierra Leone, South Africa, Tanzania, Uganda, United Arab Emirates, Zambia

Hebrew – Israel (labeling for home-use medical devices)

Arabic – Saudi Arabia (labeling for home-use medical devices), Israel (labeling for home-use medical devices), Egypt (labeling for home-use medical devices

French – Senegal

This content was compiled in April 2020. As global regulations and requirements are constantly changing worldwide, Argos Multilingual and Global Simple suggest that you do your own validation of the requirements outlined above to ensure that they have not changed.