With strict guidelines in place for regulating medical labeling worldwide, how does multilingual desktop publishing (DTP) enable companies to comply with content and design requirements during the medical label translation process? For life science companies, all types of medications, devices, and equipment are regulated to the point of specific formatting, design, and layout standards for the labels, which are required to bring these products to market and reach end users. In addition to the language requirements defined by EU and US regulators, complying to the specificities of label translations and design can be a headache for many companies and thus prompts help from a language service provider (LSP) well-versed in multilingual DTP and medical translations. To help companies through the label translation process and meet the regulatory requirements of both domestic and international markets, multilingual DTP is a crucial localization solution that leverages the best aspects of translation and digital design to deliver high quality, and perfectly formatted medical labels.
Multilingual Desktop Publishing (DTP): How it Works
Multilingual desktop publishing (DTP) occurs at the end of the translation process and involves redesigning, shaping, and formatting a document’s figures to be in accordance with international topographic rules and standards. Depending on either the target and source language, the difference in characters, letters, spacing, and general readability of the language will greatly affect how the text fits alongside the required figures, and thus mandates a complete reformat and redesign of the label. During DTP, localization experts utilize DTP software, such as Adobe FrameMaker, Adobe Acrobat, or QuarkXpress, to create different layouts for figures like graphs, charts, tables, and images. While DTP can generally be applied to a wide range of content, it is especially useful for medical labels, including:
- In-Vitro Diagnostic Device Labels
- Medical Device Labels
- Instructions for Use (IFU)
- Medication Labels
- Patient Record Labels
- Surgical Instrument Labels
- Medical Lab Labels
Whether you are preparing to bring products in the EU or US markets, localization experts can use DTP to add in key symbols, such as CE Markings and serial numbers, to ensure the label meets all current regulatory requirements. Additionally, while knowledge of the regulations is key, swift turnaround times are essential during DTP projects, as many countries and markets have tight deadlines for submission.
Achieving Regulatory Compliance for Your Product Labels
Bringing medical products to market in any country requires an understanding of the specific regulations in place that govern product specifications like labels. For instance, the EU’s chief medical regulator, the European Medicines Agency (EMA), has in place regulations like the EU-MDR for medical devices, which further requires labels to include special a special CE Marking for approval. Similarly, the US Food and Drug Administration (FDA) has general provisions for labels, which detail requirements such as the listing the product’s intended use, the name and address of the manufacturer, and directions for use spelled out in layman terms. So, regardless of the intended market or target language of your medical label, an effective multilingual DTP solution can be a quick and effective strategy for reaching end users and ensuring the best ROI. While this process can be challenging for many companies working in today’s competitive medical industry, experienced LSPs like CSOFT Health Sciences have the expertise to deliver the multilingual DTP solution that you need gain compliance and enter global markets. Visit lifesciences.csoftintl.com to learn more.