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Medical Translation: Requirements for Medical Device Manufacturers

August 16, 2017 – The medical devices sector is an ever-growing industry on a global scale, covering a wide range of diverse and innovative products, from simple bandages to implants and prostheses to high-tech nanotechnology applications and surgical robots. The global medical device, technology and equipment market is estimated to reach US $434.4 billion in 2017. Whether the market is steadily growing or booming in an emerging market―like Brazil, the “economic powerhouse” in Latin America and currently one of the world’s fastest-growing economies―the continuous expansion in the medical devices sector in all regions of the world creates attractive economic opportunities for medical device manufacturers. However, the process of launching a product in a foreign market requires overcoming administrative and linguistic hurdles presented by stringent and diverse regulatory requirements.

Medical Translation: A Staggering Volume

The import and distribution of medical devices in a foreign market is subject to strict compliance measures and approval processes set by a regulatory body in the target country. Although regulations differ from one country to the next, they have the common requirement that materials and content accompanying the medical device such as packaging and labels, instructions for use (IFU), user interface and software, marketing materials and any patient- and/or caregiver-focused documentation must be translated in the official language(s) of that country. The regulations have a huge demand for professional medical translation and related services.

Besides the user-facing content, which understandably must be made available to medical professionals and patients in the official language(s) of the target country, all of the product-related documentation that will be used by regulators to assess the device and eventually approve its import and distribution on the target market must also be translated. This documentation includes clinical trials, study-related tests and procedures, quality management system certificates, compliance with principles of safety and effectiveness and various administrative documents.

Different Countries, Different Rules

The volume of translation required to launch a medical device in a foreign market may already seem staggering. Yet medical device manufacturers must also take into account that some countries have more than one official language, and therefore, the materials and content accompanying a medical device must be made available in all or some of these languages before the device can be approved for distribution in the target country.

Launching a product in the European Union market, for example, may not be as straightforward as it first seems. If the term “Union” conveys the idea of unity and consistency, the diversity of the translation requirements for medical devices required by the various EU member states often catches manufacturers off-guard. For example, Belgium requires material to be translated in its three official languages (French, Dutch and German) and Finland requires the same in Finnish, Swedish and English. To add to the confusion, EU member states have different requirements as to what type of content must be translated based on the category and whether the content is for a “professional user” or a “public user.” In Finland, public content must be in Finnish and Swedish, but professional use content must be in Finnish, Swedish or English. Bulgaria allows software to be available in English. And finally, Cyprus, Luxembourg, Malta and Poland accept English for medical device labelling if the device is for professional use only. As you can see, it’s not straightforward.

In Canada, where English and French are the official languages, the Guidance for the Labelling of Medical Devices states that instructions for use for medical devices sold to the general public must be available in both official languages at the time of purchase. However, instructions for all other medical devices must be provided in only one of the official languages at the time of purchase, but instructions in the other language must be made available upon request of the purchaser.

Israel, for example, requires all medical device labelling to be available in Hebrew. Although both Hebrew and Arabic have been the statutory national languages of Israel since 1922, no provision exists to also provide the medical device information in Arabic.

Regulations in Constant Flux

Regulations overseeing the medical device sector are constantly changing and so are the regulatory translation requirements, which are undeniably an integral component in the medical device approval process. Regulations of medical devices are steadily evolving to take into account leading-edge technologies and innovations, which requires language professionals to keep abreast of the increasing complexity of medical procedures and terminology.

Regulations are also changing in step with the economic evolution worldwide. Emerging economies, which have always presented tremendous export opportunities for global medical device manufacturers of developed economies, eventually reach a higher economic level. This results in higher incomes and standards of living, and a growing demand for quality health care.

In the past decade, China has become an important market for medical devices and is currently the fourth largest medical device market in the world after the USA, Germany and Japan. China’s State Food and Drug Administration (SFDA) has updated or implemented regulatory requirements in this field several times to keep pace with the ever-growing medical industry in China and to reinforce control over imported devices. In place since 2000, regulatory requirements were changed in 2004 to mandate that external labelling and packaging of medical devices include a version in Mandarin Chinese. The language requirement was changed again in 2013 to state that the Chinese labels must be affixed to medical devices before they enter any Chinese territories. In 2014, medical device regulations were significantly revised again to establish more efficient and scientific controls over the safety and reliability of medical devices.

Understandably, regulatory requirements are also a measure that allow many countries to reclaim parts of the market for local manufacturers and ensure free and fair trade of the products. In 2012, Korea’s Food and Drug Administration (KFDA) introduced a new certification system for foreign medical device manufacturers through an on-site inspection or document review. Medical device manufacturers must obtain a certificate before they can submit a new device application. Korea has also increased their quality standards for pharmaceuticals, amongst other changes.

Changes to the regulations can also stem from misuses. The 2010 scandal of the silicone breast implants manufactured by the French company Poly Implant Prothese (PIP) is often cited as one of the triggers that led regulatory authorities to revise EU directives for medical devices. PIP used industrial-grade silicone instead of the required medical-grade material intended for use in the human body. The scandal underscored numerous risks stemming from the lack of clarity and consistency in the regulations and pitfalls in the manufacturing quality assurance process. In 2014, the EU directive was revised to include cosmetic products without a medical need, such as implants and non-corrective contact lenses, thus further increasing the scope of required translation for manufacturers.

Changes also aim to reinforce quality requirements and reliability of medical device manufacturers and their outsourced activities. The ISO 13485:2016 quality management standard, for example, outlines obligations for manufacturers to monitor and control not only their own internal processes, but also their outsourced processes that affect their product conformity. In other words, medical device manufacturers must be accountable for their suppliers, such as translation and localization companies, who provide services related to their medical device. Because translation has become a key activity in the medical device manufacturing sector, some translation companies have decided to obtain the ISO 13485:2016 certification to meet their clients’ quality requirements. In addition, specialized medical translation services companies, such as Net-Translators, also offer exhaustive planning and translation solutions to assist their medical device clients in the entire regulatory translation process, from preparing country-specific regulatory reviews to translating and localizing content according to the specific requirements of the target market to delivering ready-to-deploy materials.

A Trend toward Standardization

In the medical device sector, translating is not a choice―it is a requirement. Significant differences in regulatory requirements by region and by country make the translation process a daunting task, but the global trend is toward a standardization and harmonization of the regulations, backed by the World Health Organization (WHO), to avoid any misinterpretation of the legislation, simplify language requirements, speed up the device approval process and facilitate access to innovative devices for patients and medical professionals.

Medical device manufacturers are also increasingly using internationally-recognized symbols instead of words to communicate important information quickly and to avoid the challenges posed by translation, such as mistranslations that may seriously harm a patient or caregiver, or text expansion that results in longer documents and layout adjustment for labels. Understandably, the meaning of the symbol has to be obvious to the device user. The ISO 15223-1:2016 standard lists the symbols used for a wide array of medical devices in many countries.

But translation doesn’t end after the medical device has passed all the administrative and regulatory hurdles and is launched in the new market. Medical devices evolve with advancement in technologies and the accompanying documentation and software must be updated in all required languages. Manufacturers remain liable for their devices throughout their lifespan and it is their responsibility to closely monitor the changes in regulatory requirements for the countries where their devices are distributed.

Medical Translation Services: Expertise Matters

Selecting the right medical device translation services company is crucial to the success of your efforts. As one of the world’s leading medical translation and localization companies, Net-Translators is compliant with all required medical ISO certification and standards. We work with three of the five biggest medical companies in the world and our reputation for thoroughness and quality makes us unique in our ability to deliver language services of the highest quality available.

For additional information or to request a quote, reach out to one of our global offices today and follow our Medical Translation and Localization LinkedIn Showcase page.

About the author:

Lee Stein, Vice President of Operations at Net-Translators
Lee SteinAt Net-Translators I’ve had a unique opportunity to experience the world of localization from different points of view! During my first years at Net-Translators, I was the HR and Vendor Manager. I had the chance to experience the localization world from different people’s perspective: translators, project managers, localization engineers, QA testers and more… Each one and his own motivations, challenges and expertise. It was very fascinating! As the VP of Operations I face new challenges together with our clients. Being committed to fulfill our clients’ requirements, goals and expectations while constantly improving our service has made me even more confident that it’s all about the people: teamwork, communication, sharing information and aiming for one common goal. In this blog I’ll share with you interesting information, thoughts and insights. You are most welcome to comment and share. Looking forward to meeting you here! Lee.


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