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Translation Requirements for International Medical Device Labeling

Aug 05, 2021

Do you know the medical document translation and labeling requirements in the countries where you plan to sell your medical device? What about the difference between labels, labeling, PILs, and e-Labeling?

Regulatory authorities worldwide view medical device labeling as an integral part of the product itself. If you’re a medical device manufacturer with plans to distribute your products abroad, you need to be prepared to meet many different labeling requirements around the globe. Failure to do so can mean that your product is denied entry to a new market, or it can even cause dire, adverse consequences for your end-users.

Introducing a new device in a new market is a highly complicated process with many regulatory hurdles. Furthermore, the regulatory requirements for medical device labeling differ significantly based on the country or region, and understanding all of the regulations is an expensive, time-consuming burden that most companies can’t afford in-house. That’s why most medical device manufacturers rely on regulatory translation services companies to deliver accurate translation and labeling solutions that fit within their budget and workflow and comply with all local and cultural requirements.

With no room for error, medical device labeling translation affects manufacturing and delivery timelines, costs for manufacturers, and exposes medical professionals and their patients to varying levels of risk. To that end, it is critical to remember that these instructions promote the successful and safe use of medical devices globally. Accurate translations are more than an advantage – they’re a necessity.

To make things easier, our updated International Medical Device Labeling Guide provides tips, best practices, and country-specific rules to help you navigate the global regulatory landscape.

International Medical Device Labeling Guide

In our newly updated guide, “International Medical Device Labeling Translation Requirements,” discover:

  • E-Labeling and the Countries that Allow E-Labeling
  • National Regulatory Requirements & Individual Country Requirements
  • The Benefits of Using a Language Service Provider (LSP)
  • Regional Authorities, in Europe, Middle East, & the Americas
  • 5 Steps to Implement Best Practices

Our complimentary guide’s rules and best practices help facilitate a comprehensive compliance process to bring your product to market while mitigating risk and supporting expedited approval. It also imparts critical information on controlling translation costs and staying on the GTM schedule.

Implementing an international labeling strategy is crucial to the successful testing, launch, and commercialization of any medical product.

The details matter, and mistakes can be costly. Do not go to market without reading our guide first.

For more information on medical document translation and to plan your international label strategy, contact us.


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