Tips for Following Medical Device Translation Regulation
In today’s global economy, the need for precise and accurate translations in most areas of manufacturing has never been greater. In some industries, such as the manufacture of medical devices, it’s not only a good idea to have accurate translations from a sales and marketing standpoint, it’s a requirement from various regulatory bodies in most foreign countries to which medical devices are exported. Critical information regarding safety related information and operating instructions must be easily understood in the native language of those who will be using, selling and maintaining this medical equipment.
The international marketplace is vital to the profitability of companies manufacturing and selling medical equipment, with some estimates indicating that between 25 and 50 percent of these devices made in the United States are sold to foreign buyers, particularly in Europe, China, Korea and Japan. According to a study by the Emergo group on the medical device industry, North American medical device suppliers showed a 55% growth in international sales in 2011, as did 51% of European firms. Not surprisingly, plans to grow in Brazil, China, and India were planned for 2012.
Just as the Food and Drug Administration is the regulatory body overseeing the manufacture, sales and use of medical equipment in the U.S., other countries each have their own regulatory bodies and their own specific sets of regulations and guidelines. European directives such as the Medical Device Directive (MDD 93/42/EEC), The In Vitro Diagnostic Directive (IVDD 98/79/EC), The Active Implantable Medical Device Directive (AIMDD 90/385/ EEC) aims to harmonize the differences between member states, requiring exported products to the European Union be translated into multiple languages, since different languages are spoken in different countries. While some EU countries may allow for the use of English documentation for some equipment only meant for use by ‘professionals,’ with this regulation varying from country to country, all EU nations require the use of their country’s official language(s) for safety-related materials, cleaning instructions, user instruction manuals and labeling. Other documentation may also require translation, as per local regulations, including:
- Case report forms
- Data protocols from clinical research
- Clinical study results
- Informed consent forms
- package inserts
In Japan, where the sale of medical devices comes under control of the Ministry of Labor, Health and Welfare, (the Pharmaceuticals and Medical Devices Agency) product approval and licensing that allows for the sale of medical equipment must be applied for in Japanese. In China, the State Food and Drug Association calls for safety and product use information to be translated into Mandarin Chinese before medical devices are able to enter the country.
While some manufacturers may look internally to fulfill translation requirements, such as multilingual employees, for example, others may depend on their product distributors or representatives for assistance. This may work adequately in some instances, but medical translation requires a tighter, more accurate and precise process that is edited, validated and rechecked by experts. The best way to accomplish this is through the use of professional translation agencies with staff specifically knowledgeable and experienced in the area of life sciences and, particularly, in the area of medical device translation. In this area of expertise, it’s not enough to just speak the language, but one must be a specialist. Familiarity with the terminology, regulatory and compliance issues and processes specific to medical devices is vital.
Your language services provider (LSP) or translator should have the knowledge, the experience and, most importantly, speak the language of the regulators. One way to ensure your translator or LSP provides quality translation is by making sure they follow international and national standards like the ASTM standards for language quality. At CETRA, we are a member of the US delegation to the ISO Technical Committee 37 and the ASTM F43 Committee on language quality. CETRA is also ISO 9001 and ISO13485 certified.
