Gal Yissar, Net-Translators, Ltd.
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 through implants and prostheses to high-tech nanotechnology applications and surgical robots. Valued at US $360 billion in 2014, the global medical device, technology, and equipment market will reach an estimated US$434.4 billion by 2017. Whether the market is in steady growth in one country 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 on a foreign market requires overcoming administrative and linguistic hurdles raised by stringent and diverse regulatory requirements.
A Staggering Volume of Translation
The import and distribution of medical devices on 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–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 of that country.
Besides the user-facing content, which understandably must be made available to medical professionals and patients in the official language (or languages) 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
If the volume of translation required to launch a medical device on a foreign market is already staggering, medical device manufacturers must also take into account that some countries have several official languages, and therefore, the materials and content accompanying a medical device must be made available in all or some of these language before the device can be approved for distribution in the target country.
Launching a product on 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 and Swedish. In addition, EU member states have different requirements as to what type of content must be translated. While most of the member states enforce the availability of the entire content in their official language, others, such as Bulgaria, allow 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.
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 other medical devices can 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 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 economical evolution worldwide. Emerging economies, which have always presented tremendous export opportunities for global medical device manufacturers of developed economies, eventually reach a higher economical level resulting 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, formerly known as the CFDA) has implemented regulatory requirements in this field several times in the past years 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.
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 because the company 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. The new 2014 regulations decisively affect the translation volume and process, because the revised directive now includes 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 13485:2003 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 who provide services related to their medical device, such as language services providers (LSPs). Because translation has become a key activity in the medical device manufacturing sector, many LSPs have decided to obtain the ISO 13485:2003 certification to meet their clients’ quality requirements. In addition, an increasing number of LSPs 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, through 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 also increasingly use 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 15223-1:2012 standard lists the symbols used for a wide array of medical devices in many countries.
But translation does not end after the medical device has passed all the administrative and regulatory hurdles and is launched on 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 the lifespan of the devices and it is their responsibility to closely monitor the changes in regulatory requirements for the countries where their devices are distributed.
Medical Device Translation Expertise
Net-Translators specializes in translation and localization services for the medical device industry. Together, our reputation for thoroughness and quality, ISO certification for the medical industry, and extensive experience working with medical industry leaders make us unique in our ability to deliver language services of the highest quality available while helping you navigate the many and varied requirements of this intricate, accuracy critical process.
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