Translation for Medical Devices

Global Translation provides a wide range of translation services for medical device companies in English, German, Spanish, Italian, French, Chinese, Japanese and over 50 other languages.

CE marking is a necessary step for exporting medical devices in Europe. Medical device companies need to contract a notified body in Europe to perform the CE registration. The notified body will take care of all registration paperwork, and will translate the necessary documents needed to obtain the CE mark. In addition, if you do not have an address in Europe you will need to contract an agent that will act as your European representative. However, the regulatory headaches don’t end with the CE mark. Some of the EU member states may require that translations of safety documents, user documentation and other material must accompany all medical devices sold within their country.

There are three directives relevant to medical device equipment. These directives regulate the sales of medical devices within the EU:

• Council Directive 90/385/EEC 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 14th June 1993 (Medical Device Directive)
• Directive 98/79/EC of the European Parliament and of the Council of 27th October 1998 on in vitrodiagnostic (In Vitro Diagnostic Medical Device Directive)

Within the framework of these directives, EU member states can determine additional, country-specific requirements for medical device companies. Each country should be examined separately as requirements vary. As of the end of 2006, there are 25 member states and 20 EU languages in the EU. This will grow to 28 member states and 23 languages at the beginning of 2007, with the addition of Ireland, Romania and Bulgaria to the EU. The European Free Trade Association (EFTA) is an alternative for European states that were not allowed or did not wish to join the European Community (now the EU). Today the EFTA members are Switzerland, Norway, Iceland and Liechtenstein.

Larger companies will typically do the translations themselves, either in-house or through a translation company. Some smaller companies leave the task of translation to their local distributor or representative. When this is the case, it is recommended that the medical device company oversee the translation process in order to maintain a high level of quality. Very often, we find that local distributors, in their efforts to cut costs, provide low quality translations that could adversely affect the sales performance in the target country. One of the ways to check whether the translation is of good quality is to order a back translation and then compare the original with the back translation to see if there are any errors.

MARKETING MEDICAL DEVICES IN ASIA

Translation plays a key role for companies that wish to sell medical devices in Asia. Most Asian countries have their own regulatory and safety requirements and all countries require translation of a wide range of documents and labelling into the local language. Pre-market approval must usually be obtained from the regulatory authorities in that country. Most Asian countries issue product licenses only to locally based firms, so all foreign suppliers must submit required documentation and receive necessary approvals through their Asian distributors if the company does not have a subsidiary in that country. As mentioned previously, medical device manufacturers should take an active part in overseeing the quality of translated material, especially documents that are part of the product package.