The top three receivers of U.S. medical devices include Germany (also the top spender of healthcare in Europe), Japan and the Netherlands. Analysts expect growth to continue steadily in the next decade, with over 50 percent of medical device manufacturers admitting that business growth opportunities are fueled by overseas demand.
“U.S. medical device companies are highly regarded globally for their innovations and high technology products. Investment in medical device research and development more than doubled during the 1990s, and research and development investment in the domestic sector remains more than twice the average for all U.S. manufacturers,” said Select USA, an organization that specializes in disruptive businesses and investments.
Challenges and Obstacles
Due to the complex nature of the industry, many medical devices companies are at risk of facing compliance issues when expanding to foreign markets around the world. For example, when offering products in Canada, businesses must closely adhere to various French translation guidelines. Mexico requires the translation into Spanish of the label with information as required by Official Mexican Norms and the Instructions for the device’s use or operation manual. While Brazil’s healthcare translation requirements are dictated by Anvisa, Malaysia’s medical device regulations are similar to the classification scheme used in the European Medical Device Directive (MDD) 93/42/EEC. In Belgium, foreign products must come with translated material in the following official languages: French, Dutch (Flemish) and German. Finland shares similar requirements but for Finnish and Swedish. When it comes to labeling, Poland, Cyprus and Luxemburg only accept English formats if the unit is designed “for professional use only.” Saudi Arabia requires medical products consumed by laypeople to be translated into Arabic.
Failing to meet the regulatory standards of foreign markets could lead to product delays, a reduction in long-term profits and costly legal battles. Other possible outcomes include the following risks:
- Seizure of products at the border of the importing country
- Hindrance in the ability to be protected by liability insurance
- Product recalls
In 2010, Poly Implant Protheses (PIP), a French medical devices company, went bankrupt after it used industrial-grade silicone in one of its breast implant products. The case cited the possibility of clarity issues on the manufacturing label of the unit, which caused clinics in the EU region to misuse the product. New regulations in 2014 were created to prevent such occurrences from happening again. Businesses that are interested in protecting their offerings from crippling lawsuits that arise from improper translations may consider partnering with a professional language translation company to ensure compliance.
Staying updated with the latest regulatory requirements of a foreign region is another component that businesses in the sector must continuously oversee. China, the fourth largest medical devices market, is known for updating its translation requirements to enforce control over imported medical products. In 2000, China’s State Food and Drug Administration (SFDA) set forth guidelines on the proper labeling and packaging of medical devices. The recommendations were revised in 2004, 2013 and 2014 to require all outside labeling and packaging of medical devices to include a version in Chinese. The latest revisions also focused on tighter controls over the safety of specific products.
“U.S. medical device manufacturers should also be concerned about foreign regulations, particularly in China, which is pursuing policies that favor domestic manufacturers. This may force U.S. medical device manufacturers that want to sell in China to manufacture there. This creates a predicament because companies will need to rely on China’s intellectual property laws and enforcement, which have been major concerns to date,” explained Jamie Hartford from MDDI.
The Ideal Language Translation Company
Not every language translation company is equipped to handle your Medical Device translation requirements. Experienced staff in regulatory requirements and translators in medical terminology are both essential! Couple that with ISO Certification, exemplary quality and service levels and an impressive list of clients in the field and you have the potential of a long term successful partner. One that will help you navigate the international rough waters ahead of you…
Read our whitepaper 5 Case Studies in Medical Device Translation and Localization, and register to attend the 15 minute free healthcare localization webinar.