Why do device companies treat Japan differently?
Written by ForeignExchange Translations on Thursday, July 09, 2009
As we noted before, many device companies doing business in Japan rely on their local affiliates to handle the creation of regulatory documentation.
While this approach makes sense on the surface (language and cultural considerations come into play), there are big problems that come with doing business this way. The most serious? HQ doesn't know what was submitted to the government, which can have serious implications.
The Japan dossier preparation and translation process requires a unique approach. Cooperation among submission authors, the translators and the Japanese affiliate is essential to make it work. When it does, a company can be assured that its English and Japanese submissions stay consistent, and there are no questions about what is submitted. It has the side benefit of building cross-cultural teams, where both parties focus on their core competencies.
One of our audio conference shares Japan-specific experiences around how regulatory documentation gets translated, different approaches companies take for their Japan dossier creation.
If the "usual approach" no longer works for your firm, take a look at these best practices for creating consistent, accurate, and timely submissions.
If you have your Japanese regulatory submissions working at 100% efficiency, move along. Otherwise, subscribe to the Medical Translation Insight via email or RSS.
