The global market for medical devices continues to grow, even as an already large industry. So why aren’t more companies exporting their medical devices?
In 2014 the global market for medical devices totaled $340 billion, of which $45 billion came from the export of US medical devices. Still, many US-based medical device companies are wary of exporting their products. According to September Secrist, the global healthcare team leader at the Federal US Commercial Service office, opportunities for medical device exports remain vast, “Ninety-six percent of the world’s consumers are outside of the United States, so if you’re not exporting, it’s just like leaving money on the table.” Secrist goes on to say that the medical equipment sector is, “fairly recession proof… Many countries have already committed to national health plans with budget and development goals…
Exporting – Regulations Vary by Country
Many countries have different or changing regulations. India, China, Japan, South Korea, and Brazil all announced significant regulation changes for the end of 2015. Some are getting more restrictive—India created an new regulatory body for their medical device industry—and some are becoming more relaxed—Japan is now allowing more registrants to utilize third-party certification from Registered Certification Bodies instead of only being able to use Pharmaceutical and Medical Devices Agency (PMDA) reviews. The changing regulation climate is one reason companies may express reluctance to export their goods.
When exporting medical devices to Europe devices must get a CE Mark—from the French term “Conformité Européenne,” meaning “European Conformity”—verifying that their product is in compliance with EU legislation and is safe to be sold. One requirement for obtaining a CE mark is translation for export: all verbiage relating to the safety of the product must be translated into the primary languages of all countries the device will be exported to.
One regulation you can plan for? Translating from English to other languages.
Foreign Language – An Export Requirement You can Control
When marketing a device to foreign countries, companies should expect to translate all documents—marketing materials, packaging, labels, Instructions for Use, softwares, etc.—into at least the official languages of that country, keeping in mind that many countries have more than one official language and popular unofficial languages. However, while many countries have many languages, translated materials may be used in other countries too. French translations may be used in France, Belgium, Switzerland, Benin, Burkina Faso, Burundi, Cameroon, Central African Republic, Chad, Comoros, Côte d’Ivoire, Democratic Republic of the Congo, Haiti, Luxembourg, Madagascar, Mali, Monaco, and Niger to name a few.
When choosing a provider of translation for export, make sure to choose someone with a proven track record, knowledge of dialect differences, and an expertise in the medical industry.