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.)  There are also 64 countries without a regulatory agency governing the registration of medical devices.  These are not covered in this article.
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:
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.
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.
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.
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.
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 Countries with regulatory bodies that are not treated in this article: Afghanistan, Albania, Algeria, Azerbaijan, Bahrain, Bangladesh, Bosnia/Herzegovina, Burkina Faso, Cabo Verde, Cameroon, Ethiopia, Fiji, Gabon, Georgia, Iran, Iraq, Jordan, Kazakhstan, Kuwait, Kyrgyzstan, Laos, Lebanon, Libya, Madagascar, Maldives, Moldova, Mongolia, Montenegro, Morocco, Myanmar (formerly Burma), Oman, Pakistan, Papua New Guinea, Philippines, Qatar, Samoa, Sri Lanka, Sudan, Thailand, Togo, Tunisia, Tuvalu, Uzbekistan, Vietnam, Yemen and Zimbabwe.
 Countries without body regulating medical device registration: Andorra, Angola, Antigua and Barbuda, Armenia, Bahamas, Barbados, Belize, Benin, Bhutan, Botswana, Brunei, Burundi, Cambodia, Central African Republic, Chad, Comoros, Congo (Congo-Brazzaville), Côte d’Ivoire, Democratic Republic of the Congo, Djibouti, Dominica, Dominican Republic, Equatorial Guinea, Eritrea, Eswatini, Gambia, Grenada, Guinea, Guinea-Bissau, Haiti, Kiribati, Lesotho, Liberia, Malawi, Mali, Marshall Islands, Mauritania, Mauritius, Micronesia, Mozambique, Nauru, Nepal, Niger, North Macedonia, Palau, Palestine State, Rwanda, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, San Marino, Sao Tome and Principe, Seychelles, Solomon Islands, Somalia, South Sudan, Suriname, Syria, Tajikistan, Timor-Leste, Tonga, Turkmenistan and Vanuatu.