Do I Need to Translate to Sell Medical Devices in the European Union?

Do I Need to Translate to Sell Medical Devices in the European Union?

by Translation Guy on January 12, 2017
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While a significant percentage of doctors in the European Union speak and read English to a high standard, not all of them do. But more importantly, that figure is much lower among the general population and potential users of your medical device. What about the regulations though? In a previous post we talked about some of the opportunities the European Union presents for US medical device firms looking to expand abroad, such as the unified regulatory approval process, but also the requirements for translation. Let’s take a closer look at those translation requirements. In most EU countries, or if your medical device is intended to be used by patients or users from the general public, your firm will need to translate the patient or user information into the national language(s) of each EU country you intend to commercialize the medical device in. This information typically includes the instructions for use (IFU) as well as the device's packaging and labeling. Translating this information allows those who will use the medical device to know how to properly use it. That said, translation is not always mandatory. In a small number of EU countries, labeling in English only is permissible when the medical device is intended for professional use only. Even if translation is not compulsory, however, there are other reasons for your medical device firm to opt for translating user information. Chief among them is exposure to liability. In the case of an injury or death associated with your medical device, choosing not to translate relevant information about the device can unnecessarily expose your firm to liability lawsuits or having to pay for damages. In addition, not translating patient information has the potential to prevent you from being covered by liability insurance. In other words, translating user information is an easy way to guarantee continued success for your medical device. Translation doesn’t just help you speak your medical device user’s language and allow them to properly use the device; it helps ensure regulatory compliance and reduces liability exposure. For additional information or to discuss your specific translation requirements, please get in touch at 212-355-4455 ext 208 or kclark@resptrans.com.

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Opportunities for US Medical Device Firms in the European Union

Opportunities for US Medical Device Firms in the European Union

by Translation Guy on December 29, 2016
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While the United States is currently the largest market for medical devices, the European Union presents significant opportunities for US medical device firms looking to expand abroad. The European Union's medical device market represents the second largest in the world; it's worth 100 billion euros and accounts for 31% of the entire globe's medical device market. (To compare, the US accounts for 40%.) A few of the reasons the European Union is an attractive place to expand are that it has a large population, it spends a significant amount on health care and medical devices, and it offers a unified regulatory framework.  

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Language, for Love or Money

Language, for Love or Money

by Translation Guy on December 22, 2016
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This Polish Christmas ad brought tears to our eyes. See it for yourself.

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Translators’ Hall of Shame: Part V

Translators’ Hall of Shame: Part V

by Translation Guy on December 21, 2016
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Another roundup of bad translations just in time for the holidays. Instead of easy Xmas chimney access, bad translations add fuel to the fire scorching Santa's... well, you get the idea. Here are three recent examples.  

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New Opportunities for Medical Device Firms in Emerging Markets

New Opportunities for Medical Device Firms in Emerging Markets

by Translation Guy on December 14, 2016
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With more than two billion underserved patients in emerging markets around the world, medical device firms have plenty of room for global growth. This includes underserved patients in countries like India and China, as well as in regions like Latin America, Southeast Asia, the Middle East and Sub-Saharan Africa. While each market has its own unique characteristics, there are still some important points in common. Let's take a look at some of the influences on emerging markets that will be relevant for medical device firms for the next 15 years or so.  

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Trends in the World’s K-12 Test and Assessment Market

Trends in the World’s K-12 Test and Assessment Market

by Translation Guy on December 8, 2016
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Education represents an important investment around the globe for students, teachers, parents and government. But how do you know what students have learned and more importantly, what they haven't? K-12 tests and assessments help educators answer those mission-critical questions. The regular administration of tests and assessments is currently recognized as an important part of education. It provides benchmarks for student performance as well as opportunities for improvement. What are other factors likely to come up in the next five years or so?  

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What Languages Do They Speak?

What Languages Do They Speak?

by Translation Guy on December 5, 2016
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interpreting-download-graphic Do you know what the most common languages spoken in each country are? Many countries have more than one language spoken within their borders. And people in some countries speak more than one language. Here you can find out what languages are commonly spoken where. Afghanistan Dari, Pashto Albania Albanian Algeria Arabic, French, Berber Angola Portuguese, Umbundu, Kikongo, Kimbundu, Chokwe Argentina Spanish Armenia Armenian Australia English Austria German, Slovene, Croatian, Hungarian Azerbaijan Azerbaijani Bahrain Arabic Bangladesh Bangla Belarus Russian, Belorussian Belgium Dutch, French Belize English, Spanish, Creole, Maya Benin French, Fon, Yoruba Bhutan Dzongkha, Sharchhopka, Lhotshamkha Bolivia Spanish, Quechua, Aymara Bosnia and Herzegovina Bosnian, Croatian, Serbian Botswana Setswana, Sekalanga, English Brazil Portuguese Brunei Malay Bulgaria Bulgarian, Turkish Burundi Kirundi, French Cambodia Khmer Canada English, French Cape Verde Portuguese, Criuolo Chad French, Arabic, Sara Chile Spanish China Standard Chinese (Mandarin), Yue (Cantonese), Wu (Shanghainese), Minbei (Fuzhou), Minnan (Hokkien-Taiwanese) Colombia Spanish Costa Rica Spanish Côte d'Ivoire French, Dioula Croatia Croatian Cuba Spanish Cyprus Greek, Turkish Czech Republic Czech Denmark Danish, Faroese, Greenlandic Djibouti French, Arabic, Somali, Afar Dominican Republic Spanish Ecuador Spanish, Quechua Egypt Arabic El Salvador Spanish Equatorial Guinea Spanish, French, Fang, Bubi Eritrea Tigrinya, Arabic, English Estonia Estonian, Russian Ethiopia Amharic, Oromo, Somali, Tigrigna Fiji English, Fijian Finland Finnish, Swedish France French Gabon French, Fang, Myene, Nzebi, Bandjabi Georgia Georgian, Russian, Armenian, Azerbaijani Germany German Ghana Asante, Ewe, Fante, Boron, English Greece Greek Guatemala Spanish, Quiche, Cakchiquel, Kekchi, Mam, Garifuna, Xinca Guinea French, Malinké, Susu, Fulani Haiti Creole, French Honduras Spanish Hungary Magyar (Hungarian), English, German Iceland Icelandic, English India Hindi, Bengali, Telugu, Marathi, Tamil, Urdu, Gujarati, Kannada, Malayalam, Oriya, Punjabi, English Indonesia Bahasa Indonesia, English, Dutch Iran Persian, Azeri Turkic, Kurdish Ireland English, Irish Israel Hebrew, Arabic, English Italy Italian, German, French, Slovene Jamaica English, Jamaican Creole Japan Japanese Jordan Arabic Kazakhstan Russian, Kazakh Kenya Kiswahili, English Kiribati I-Kiribati, English Korea, North Korean Korea, South Korean Kosovo Albanian, Serbian Kuwait Arabic Kyrgyzstan Kyrgyz, Russian, Uzbek Laos Lao, French Latvia Latvian, Russian Lebanon Arabic, French Lesotho Sesotho, English, Zulu, Xhosa Libya Arabic, Berber Liechtenstein German Lithuania Lithuanian, Russian, Polish Luxembourg Luxermbourgish, French, German Macedonia Macedonian, Albanian Madagascar Malagasy, French Malawi Chichewa, Chinyanja, Chiyao, Chitumbuka Malaysia Bahasa Melayu, English, Chinese, Tamil, Telugu, Malayalam, Panjabi, Thai Maldives Maldivian Dhivehi Mali French, Bambara, Peul, Dogon, Maraka, Malinke, Sonrhai Malta Maltese, English Mauritania Hassaniya Arabic, Pulaar, Soninke, French, Wolof Mauritius Creole, Bhojpuri, French, English Mexico Spanish Moldova Moldovan, Romanian, Russian Monaco French, English, Italian, Monégasque Mongolia Mongolian, Turkic, Russian Montenegro Serbian, Montenegrin, Bosnian, Albanian Morocco Arabic, Tamazight, French Mozambique Emakhuwa, Portuguese, Xichangana, Cisena, Elomwe, Echuwabo Myanmar Burmese Nepal Nepali, Maithali, Bhojpuri, Tharu, Tamang Netherlands Dutch, Frisian New Zealand English, Maori Nicaragua Spanish, Miskito Niger French, Hausa, Djerma Nigeria English, Hausa, Yoruba, Ibo, Fulani Norway Bokmål Norwegian, Nynorsk Norwegian Oman Arabic Pakistan Urdu, English, Punjabi, Sindhi, Saraiki, Pashto Panama Spanish, English Papua New Guinea Tok Pisin, Hiri Motu, English Paraguay Spanish, Guaraní Peru Spanish, Quéchua Philippines Filipino, English Poland Polish Portugal Portuguese Qatar Arabic Romania Romanian, Hungarian Russia Russian Rwanda Kinyarwanda Saudi Arabia Arabic Senegal French, Wolof, Pulaar, Jola, Mandinka Serbia Serbian, Hungarian Sierra Leone English, Mende, Temne, Krio Singapore Mandarin, English, Malay, Hokkien, Cantonese Slovakia Slovak, Hungarian Slovenia Slovenian, Serbo-Croatian Somalia Somali, Arabic South Africa IsiZulu, IsiXhosa, Afrikaans, English, Sepedi, Setswana, Sesotho South Sudan Arabic, English, Dinka, Nuer, Bari, Zande, Shilluk Spain Castilian Spanish, Catalan, Galician, Basque Sri Lanka Sinhala, Tamil Sudan Arabic, Nubian, Ta Bedawie, English Sweden Swedish Switzerland German, French, Italian Syria Arabic, Kurdish, Armenian Taiwan Mandarin Chinese, Taiwanese (Min) Tanzania Swahili, English, Arabic Thailand Thai Togo French, Ewé, Mina, Kabyé, Dagomba Tunisia Arabic, French, Berber Turkey Turkish, Kurdish Turkmenistan Turkmen, Russian, Uzbek Uganda English, Ganda, Swahili, Arabic Ukraine Ukrainian, Russian United Arab Emirates Arabic United Kingdom English, Scots, Welsh, Irish United States English, Spanish Uruguay Spanish Uzbekistan Uzbek, Russian Venezuela Spanish Vietnam Vietnamese Yemen Arabic Zambia Bembe, Nyanja, Tonga, Lozi, Chewa, English interpreting-download-graphic

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Accent as a Joke? Speaking Swabian Perhaps?

Accent as a Joke? Speaking Swabian Perhaps?

by Translation Guy on November 30, 2016
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Accents are funny in any language. But some dialects are more likely to be the butt of humor than others. Plenty of Americans spend big money to shed those accents and avoid being the butt of jokes, or to avoid the class or ethnic discrimination they might face.  

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States Improving Language Access for Limited English Speaking Individuals

States Improving Language Access for Limited English Speaking Individuals

by Translation Guy on November 15, 2016
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Slowly but surely, the United States is expanding language access for limited English proficient individuals. In some cases it's required by law and sometimes it just makes good customer service sense. It may be time for your organization to take a look at how best to provide language services to those who could benefit. Here's the latest.  

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Checking Translations to Avoid Getting Ripped Off

Checking Translations to Avoid Getting Ripped Off

by Translation Guy on November 10, 2016
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Savvy consumers know how to stretch their budget and get their money's worth. Luckily, the same principle is true when it comes to translation. There's just one snag: As a translation buyer, it's likely you don't speak the language you need a translation for. But if you can't read the translation, how do you know you're getting what you paid for? What can you do to evaluate a translation or its quality?  

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