;   Medical Translation Insight: Best practices for Japan regulatory submissions - ForeignExchange Translations

Best practices for Japan regulatory submissionsMany medical device companies treat Japan different from other markets.

On one hand, streamlining Japanese translation processes for effective regulatory submissions is a huge priority. On the other hand, U.S.-based companies generally rely on their Japanese affiliates to handle the creation of regulatory documentation and don't know exactly what was submitted.

RAPS Focus [login required] features an article written by ForeignExchange's Jason Heaton that provides a real-world example of how companies tackle this situation.

Using the experiences of a U.S.-based medical device company, the case study details how the manufacturer transitioned from an "FDA first, then throw it over the fence" model to a Japan-centric submission process. The challenges faced by the device manufacturer were predictable: struggles over who did what, clarifying (and agreeing on) tasks and responsibilities, supplying additional training, and version control.

While the transition wasn't always easy it did provide huge paybacks. The greatest benefits to the company's business were the consistency of submissions as well as the ease with which future submissions could be processed. And, maybe as importantly, was the new-found working relationship between U.S. headquarters and the Japanese affiliate.


For more information on this topic, listen to Effective Translation Process for Japan Regulatory Submissions.


Find out more about ForeignExchange's specialized Japanese translation services for pharmaceutical and medical device companies.

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