Medical Translation Services

Whether you have clinical trials, patents, medical device manuals or case-files that need to be translated, Healthcare Translation Center can help! Our translators all have extensive medical backgrounds. They have been chosen for their knowledge and experience in specific medical fields as well as for their writing skills in the target language. All hold M.D. and Ph.D. degrees, accreditations and advanced degrees in their respective professions. Our professional medical translators are located around the globe and all have access to extensive translation memories and agency databases.

Clinical Trials

Pharmaceutical companies spend years and millions to get a new drug to market. Since the percentage of clinical trials conducted internationally is ever increasing, translation of clinical trials has now become an indispensable tool of many drug companies in order to help streamline the research process. As a leading provider of high quality localization services for the medical industry, we translate the following documents accurately and on time in over 65 languages so you can focus on conducting your trials:

  • Protocols
  • Informed Consent Forms (ICF)
  • Doctor and Patient Guides
  • Case Report Forms (CRF)
  • Patient Questionnaires
  • Patient-Reported Outcomes

Regulatory Translation

Medical translation of approval dossiers requires multiple levels of quality control and a full understanding of regulatory laws, especially the US, the European Union, and Japan. Moreover, any documentation associated with followup changes to approved products or reporting of field issues must also be translated for countries that require it. We can help you with this task and translate the following documents:

  • Dossier Translation
  • Exhibit Translation
  • Instructions for Use (IFU)
  • Software Localization
  • CMC documentation
  • Clinical Summaries

Worldwide Requirements

European Requirements

In order for non-European companies to be able to sell their products in Europe, specific regulatory requirements regarding medical products have to be taken into account:

The three European directives that address medical device equipment are:

  • 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 explain in detail how manufacturers should present their products within the European Union. The EU has specific mandatory safety requirements and certain countries may have additional requirements for manufacturers.

Russian Requirements

GOST-R certificates of conformity are required for many industries in the Russian Federation, including medical devices. GOST certificates are issued by a Russian agency called Gosstandardt (GOST) and it maintains a list of products subject to certification in Russia and also authorizes certain testing labs in the Russian Federation and internationally to perform the required testing on devices.

Asian Requirements

The same applies to Asia, most Asian countries have their own mandatory product safety standards for specific product categories. Each of these safety standards includes provisions for accurate documentation.

In 2003, China implemented a new regulation called the China Compulsory Certification Scheme (CCC Scheme). It requires manufacturers of products subject to compulsory certification to apply the new CCC Mark to their products, indicating compliance with the Chinese safety requirements.

Other countries in Asia, such as Japan and South Korea, also have entry requirements for medical device products.

Contact Us

Call us at +1-312-217-2568, or use the free quote form in the sidebar to the left, or email us at info@HealthcareTranslationCenter.com. You can also fax your documents directly to +1 (312) 803-2208; one of our project managers will call you back shortly.