Medical Translation
Medical Translation Services
In the medical world, quality translations are not a matter of luxury. They are critical! Nova Translation Ltd. provides translation services to hospitals, medical equipment manufacturers, pharmaceutical firms, clinicians, and researchers. Because localization demands total accuracy and zero tolerance for misinterpretation, we employ over 100 translators across the globe, each located in a country where their native language is spoken. Translator of Nova Translation works closely with clients to ensure that translations are 100% accurate and exceed the clients’ expectations.
How big is the medical translation challenge in the Turkey?
Acquiring medical translation services is becoming increasingly more necessary, even for Turkish companies who do not sell their products outside Turkey. In Turkey today, approximately 5 million Turkish people over the age of five – about a fifth of the population-speak a language other than Turkish at home, and almost half of these Turkish people do not speak Turkish as their native tongue. This represents a significant segment of the medical, pharmaceutical and health care market which must be addressed in different languages.
Market – 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, especially since the regulations dictated in the council directives concerning In-Vitro Diagnostic devices (MDD and IVD Directives) began requiring 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: 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) Council Directive 93/42/EEC of 14 June 1993 (Medical Device Directive)
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in-vitro diagnostic (In-Vitro Diagnostic Medical Device Directive)
These directives instruct and regulate manufacturers concerning the way they are to present their products within the European Union. The EU has enacted specific mandatory safety requirements for “MD” and has also 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 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 hints at 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.”
Market – 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.
In August 2003, China started requiring compliance with a new regulation called the China Compulsory Certification Scheme (CCC Scheme). The Scheme requires manufacturers of products subject to compulsory certification-including audio products, wire and cable, telecommunications equipment, household appliances, safety glass, motor vehicle tires and firefighting equipment, among other things – 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.
Nova’s translators are specializedin medical fields
Specialized fields require specialized knowledge, and medicine is a highly specialized field. To eliminate the risk of errors in your translation, we make it a rule to recruit only true professionals from the medical industry as translators. Most of these translation professionals have been engaged in the production of all types of medical-related documentation for various sized businesses for many years. This experience in the field of medicine has provided them with expert knowledge of the industry language and the jargon necessary for accurate translations.
Nova Translation translates a diverse range of medical documentation, including:
* MD software (UI)
* Online help files
* User guides
* Patents
* Data sheets
* Regulatory documents
* Reports
* Registration documents
* Expert reports
* Dossiers
Whatever your translation needs are, Nova Translation has a cost-effective solution that ensures that you get your products to market, conform to local regulations, and convey your message accurately and professionally.
Find out about the European language requirements.
