Medical Device Regulations When Entering New International Markets

Medical and Technical Document Translation Services Supporting Device Manufacturers

Medical Device Translations for International MarketsGetting medical device labels, instructions and promotional materials ready for international markets can often be a daunting task. And this simple fact is why medical device manufacturers need to partner up with top-tier medical and technical document translation services able to craft polished, and regulatory compliant medical device regulations.

When it comes to gaining approval from regulatory agencies overseas, and then marketing your medical devices to foreign medical institutions and the general public, spot-on medical translations and pinpoint localization strategies form the bedrock of any successful approach to entering an unfamiliar region. Let’s take a look at three essential steps — along with a few translation and regulatory snares to avoid — that when dealt with correctly should help your company ease its medical gear into new foreign markets.

Work with Medical Device Regulatory Specialists

Plan on tapping into the medical device business in a steadily growing market like India? According to the Indian Government’s Department of Pharmaceuticals opens in a new window, India’s medical device marketplace could reach 50 billion USD by 2025, which is reason enough to be on the hunt for quality Hindi translation services. But when it comes to medical translations, it makes a lot of sense to work with a service that also specializes in medical device regulations.

Device packaging and labeling requirements differ from region to region, ranging from the rules governing medical language translations and terminology, to the size of the text used, or where the text should be located on the packaging. Your company will also likely need to obtain some form of documentation certifying that the medical translations and labeling are accurate, and formatted to national or regional standards.

In our example above, a translation team that has experience working with medical device regulatory bodies in India could not only offer Hindi translation services, but also help prepare a company for any regulatory hurdles that might come from agencies like the Central Drug Standards Control Organization (CDSCO), which regulates India’s medical industries. Knowledgeable regulatory specialists will steer your business away from making any costly, time-consuming errors during the translation and submission processes, which should expedite your product’s entry into the local market.

Pay Close Attention to Instructions for Use (IFU) Labeling

Once you’ve looked at some medical and technical document translation services, and found a service with regional and international regulatory experience, make sure you pay close attention to your instructions for use (IFU) labeling when translating. IFU and DFU (directions for use) text needs to be handled with the utmost care when launching a device in a specific country for governmental approval, testing and marketing. The same goes for introducing medical devices across broader, more unified regions, like the European Union.

Medical device regulators are very strict bodies and you should heed their advise. If your IFU translations are lacking in any manner, expect your regulatory approval requests to be denied. Even worse, a poorly translated IFU can open a manufacturer up to all kinds of liability issues (lawsuits, fines and more), which is why the IFU translation process should always be dealt with in a smart and professional manner. 

Luckily, international ISO standardizations have been created, and are vigorously being promoted, for medical device symbols. This standardization push takes some of the guesswork out of the IFU translation process. A well-staffed medical language translation service can offer advice, and address any other concerns you might have about device labeling, or the maze of regulatory guidelines prevailing over the region, or regions where you plan on operating.

Think Regionally About Medical Device Regulations

Initiatives like the International Medical Device Regulators Forum (IMDRF) can be immensely helpful for device manufacturers. Since differing rules govern medical devices depending on where you’re setting up shop, any advantages offered by likeminded global regulators looking to land on the same regulatory page should be seized upon by you and your medical language translation service. The IMDRF’s stated mission is to “accelerate international medical device regulatory harmonization and convergence.”

With members from Australia, Brazil, Canada, China, the European Union, Japan and the United States, the IMDRF has been making it so manufacturers can now count on more and more unified regulatory zones. For example, NAFTA countries are covered by the FDA’s Device Development Process opens in a new window, while EU nations are covered by an evolving (and hopefully improving) general regulatory framework opens in a new window.

By thinking regionally about medical devices whenever possible, medical device translation services (and manufacturers) can build better translation strategies that are often able to deal with more than one country at a time. NAFTA countries require medical device labels in English, French and Spanish, which is a prerequisite that can frequently be addressed by using a single, multi-language label. This type of regional approach can save companies time and money when properly understood and applied, ensuring that life-enhancing medical technologies can enter overseas markets as efficiently as possible, and help those who need them the most.

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