Translating your medical device into international success

Getting a new medical device out into overseas markets can be a complex task. Timelines can be excruciatingly long and the process of approval by all the relevant bodies may at times feel like a minefield. High quality, accurate translations maximise your chances of success.

So why translate?

Don’t think of translations as a red-tape requirement. Rather, they are an opportunity to promote your product and demonstrate your dedication to the local market, while maximising exposure. Market acceptance is one of the key drivers to keep in mind.

Whether the device is intended to be used by a qualified professional at a medical facility or an end-user patient in the convenience of their own home, having patient safety at heart, you will want to ensure that they know exactly how to use the product in an appropriate manner. This way your brand is also well protected from any potential litigation.

From the compliance angle you will likely already have the awareness of applicable medical devices regulations by the European Medical Devices Directives (MDD) and the fact that a medical device cannot be marketed until it has regulatory approval, which is indicated by a CE mark. Our translations ensure that you meet the relevant requirements. You might also be looking to obtain the ISO IEC 82079-1:2012 certification for your instructions for use, and ensuring that all translated versions follow suit. Make sure to check the translation requirements of the country you intend to enter with the appropriate local body.

What content can we help to translate?

Medical device QA/RA professionals often ask what exactly needs to be translated to comply with national laws. The rules for translation sometimes vary according to what is being translated and who will be reading it. In general, national language requirements for medical devices apply to (not exclusively):

  • Instructions for Use (IFU)
  • Package Inserts and Labels
  • Patient Information
  • Clinical Protocols
  • Clinical Trials
  • CRA Training Materials & Videos
  • Product Labels
  • Data Sheets
  • Production Manuals
  • Dossiers
  • Protocols
  • Questionnaires
  • Informed Consent Forms
  • Investigator Brochures
  • Regulatory Audit
  • IVR
  • Regulatory Documents
  • Manufacturing Process Descriptions
  • SAE and SOP Procedures
  • Scientific Journal Articles

If you’re considering launching your medical product into new markets and would like some advice on translations, please get in touch at info@comtectranslations.com or call us on +44 (0) 1926 335 681. We’re here ready and waiting to help.

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