In the medical world, quality translations are not a matter of luxury. They are critical! Net-Translators 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 300 translators across the globe, each located in a country where their native language is spoken. Net-Translators 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 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 revealed 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,
pharmaceutical 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, 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)
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 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.
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.
Net-Translators specialized 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.
Net-Translators 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, Net-Translators 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.
