Five tips that will take your medical device labeling to the next level

Five tips that will take your medical device labeling to the next level

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As you probably know, the medical device industry has some of the strictest requirements known, and this includes regulations that govern what you’re allowed to put on your packaging. To be successful, whether in the US or abroad, you need to ensure that you’re in complete compliance with the requirements of each country you enter. But, simply adhering to regulations is not always enough. For example, have you thought beyond the content placed on your product’s packaging? We’ve taken a look at improvements that you can quickly make to device instructions and marketing material that will help to ensure compliance and reduce risk. 

Tip 1: Use symbols y

By including symbols in your device labeling content you can minimize the amount of space used, provide consistent meanings across translations, and help users better understand what they need to know about your product. In addition, when you use symbols that people are familiar with, regardless of the language they speak, you’ll be minimizing liability for your brand.

Not sure which symbols to consider? You should use symbols that portray common phrases across all languages, such as:

    • “Use By”
    • “Sterile”
    • “Storage Temperature”

Once you decide on the symbols you want to use, be sure that you’re compliant with the regulations that govern medical device labeling in the countries you already have a presence in or are in the process of entering. 

Tip 2: e-labeling, not just a nice to have

Not only does e-labeling enable you to expand the information you provide about your medical device, it also provides benefits such as:

    • Alleviates the common problem of not having enough packaging space to provide product information in multiple languages.
    • Reduces your costs by limiting your spend on packaging, paper and printing.
    • Simplifies and quickens the process of making labeling changes or enhancements.
    • Provides a better customer experience by making device information easy to find, and providing more detailed information on the product and its usage through photos and videos.

Just remember that e-labels also are regulated, so be sure that your copy, videos and images are in compliance with the country’s regulations. For example, the EU’s medical device regulations require that device manufacturers, who have a website, publish user information on their site. And keep in mind that other countries may have similar requirements.

Tip 3: Go beyond translation requirements

Even if the countries you sell your products in only require that your product packaging be translated into the local language, it’s wise to go beyond that and translate all the content that you provide to your English-speaking market. Let’s assume that you have e-label info on your website, as well as content within blogs and other resources, by making your website multilingual your customers, regardless of the language they speak, have access to all of the same information.

It can’t be stressed enough that you need to have a clear understanding of the individual country’s translation requirements. If you decide it’s not worth the translation investment, your product might be rejected at customs, or you might not be eligible for liability insurance in the country that you’re trying to export to. In addition, there are other risks of not translating, such as having to recall your products or even being sued, should a user experience injury or death from your product. These potential liabilities are far more costly than having the label and related material translated.

Tip 4: Don’t exceed approved claims

Regardless of whether it’s a claim that your device produces certain results or a promotional statement that’s used in marketing material, it’s essential that the claims you make don’t exceed those previously approved. Today, authorities are spending more time assessing promotional statements for validity. When a company is found exceeding approved claims, the product and even the company itself can be at risk.

Tip 5: Put safety first by working with an LSP

Because translation is an essential component of launching your medical device in a new country, it’s imperative that you partner with a language service provider (LSP) that adheres to ISO certifications and other regulations that are specific to your field. The LSP that you choose should put the safety of your customers first. And this means that all product labels and subsequent product information should be clearly translated on product use, potential side effects or any other issues that the user may experience.

Summary

Don’t let regulations slow your entry into new markets. By using these medical device labeling tips, you’ll be able to streamline the entrance process and quickly be on the road to international success. If you’d like to learn more about how BURG Translations helps you ensure high quality medical device translations, contact us today.