In the medical world, quality translations are not a matter of luxury. They are critical! If you need to translate medical device manuals and interfaces, clinical research reports, patent documentation or case-file dossiers, Net-Translators delivers quality service you can rely on.
Net-Translators provides translation services to leading hospitals, medical equipment manufacturers, clinicians and researchers around the world. Our customers include Agfa Heathcare, GE Healthcare and Versamed.
Because localization demands total accuracy and zero tolerance for misinterpretation, we employ over 500 translators across the globe, each located in the country where their language of expertise is the native spoken language.
Net-Translators works closely with all clients to ensure that translations are 100% accurate and exceed expectations.
How big is the medical translation challenge in the United States?
Acquiring medical translation services is becoming increasingly more necessary, even for American companies who do not sell their products outside the US. In the US today, approximately 47 million Americans over the age of five - about a fifth of the population - speak a language other than English at home, and almost half of these Americans do not speak English as their native tongue. The 2000 US Census shows that over 28% of Spanish speakers, 22.5% of Asian and Pacific Island language speakers, and 13% of Indo-European language speakers living in the United States speak very little English - if they speak English at all. This represents a significant segment of the medical and health care market, which must be addressed in different languages.
Market access - Europe
To sell products in Europe, all non-European manufacturers must comply with the European language requirements of the countries to which they export. European Union (EU) regulatory requirements regarding medical products have cast the localization industry into the spotlight. For example, the regulations dictated in the council directives concerning In-Vitro Diagnostic devices (MDD and IVD Directives) require that documentation for devices be translated into the native language of the countries where they are used and being sold.
Basically, three European directives directly and exclusively address medical device equipment:
Directive 98/79/EC of the European Parliament Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (the AIMD Directive)
These directives instruct and regulate manufacturers concerning the way they present their products within the European Union. The EU has enacted specific mandatory safety requirements and has allowed the European Member States to determine additional country-specific requirements for manufacturers. Annex I, point 13 of the MDD states: "Each device must be accompanied by the information needed to use it safely and to identify the manufacturer, taking in account of the training and knowledge of the potential users. This information comprises the details on the label and the data in the instructions for use." The next paragraph addresses the translation requirements stating that: "Member States may require the information, which must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another community language when a device reaches the final user, regardless of whether it is for professional or other use."
To learn more about European language requirements, click here.
Market access - Asia
Translation is also an important step for companies wanting to export their products to Asia. Most Asian countries have their own mandatory product safety standards for selected product categories. As expected, each of these safety standards includes provisions for accurate documentation in the appropriate language.
In 2003, China initiated a new regulation entitled the China Compulsory Certification Scheme (CCC Scheme). The Scheme requires manufacturers of products subject to compulsory certification to apply the new CCC Mark to their products, indicating compliance with the governmental safety requirements. See CCC Mark for more information.
China is not the only Asian country with entry requirements for MD products. Regulated products under the DENAN law in Japan are categorized as specified products (SPs) and non-specified products (NSPs). Products falling under the scope of South Korea's Electrical Appliance Safety Law, also known as the Safety Certification Scheme, require all manufacturers to obtain a mandatory South Korean Safety Mark (EK-mark) before placing products on the South Korean market. In Taiwan, the Ministry of Economic Affairs (MOEA), part of the Bureau of Standards, Metrology and Inspection (BSMI), recently issued its Measures Governing Registration of Product Certification (RPC). These mandatory Taiwanese certifications cover both electromagnetic compatibility (EMC) and safety requirements. The Bureau of Indian Standards (BIS) issues the ISI (Indian Standards Institution) Mark to qualified products in every industry from agriculture and textiles to electrical and electronic products.
What do all of these regulations mean for manufacturers of MD?
Manufacturers must submit their technical documents, as well as their product labeling, operating instructions, and manuals in the local language of the country where they will be used
Net-Translators – Medical Translation Expertise
Specialized fields require specialized knowledge, and medicine is a highly specialized field. To eliminate the risk of errors in your translation, we recruit only true professionals from the medical industry as translators. Most of these translation professionals have been engaged in the production of medical-related documentation for a variety of product types and business sizes for many years. This experience in the field of medicine ensures that you benefit from expert knowledge of the industry language and the jargon necessary for accurate translations.
Net-Translators translates a diverse range of medical documentation, including:
Net-Translators has a cost-effective solution that ensures that you will get your products to market, conform to local regulations, and convey your message accurately and professionally.
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