Instructions for use, also known IFUs, are informative labelling for patients that are found on medical devices and pharmaceutical products. An IFU gives instructions on how to properly use a medical device (including class I, II, and III medical devices), in-vitro diagnostic device (IVD), or pharmaceutical products, and gives notice of any precautions associated with using the medicine or device. The information included in an IFU helps to provide guidance on the proper use of a medication or device. It also serves to inform patients of any necessary precautions they should take. An IFU, patient label, or medication guide is especially useful when a pharmaceutical drug has complex dosing instructions.
As the world has become increasingly digital, IFUs have evolved as well. A new IFU format is the electronic information for use, or eIFU. eIFUs contain audio and video files that enable life science companies to more effectively demonstrate how to correctly handle products such as medical products. Electronic information for use is already becoming a regulatory requirement in many parts of the world. For instance, the European Union now requires life science companies to use eIFUs.
For life science companies expanding overseas, highly accurate and timely IFU translations are vital since most regulatory agencies (such the FDA, EMA, NMPA) require IFUs and eEFUs to be translated into the market’s primary language before gaining market approval. Failing to provide an accurate IFU or eIFU translation can result in loss of market access, negative brand impact, and even legal consequences like fines, lawsuits, and imprisonment. CSOFT’s global network of 10,000+ in-country linguists and subject matter experts, along with our quality assurance process and video translation services, provides life science companies with high quality and timely IFU and eIFU translations to ensure regulatory compliance and the best ROI.