Medical Translation Insight

A representative from a major medical device company recently asked us this question:

"In Europe, medical device manufacturers now need to translate the software interface (it's considered part of the device); does the same thing apply in Japan?"

With the deadline for the new MDD quickly approaching in Europe, the question of what elements of the software interface to localize for which market is being pondered across the device industry.

After querying several regulatory consultants about the current situation in Japan, the answer seems to be that localized software is nice to have and not yet required. Some of the considerations pointed out by the consultants include:

• risk management (localization would be an important part of this)
• competitive landscape
• type of device (language abilities of users)
• localization costs

As with most big regulatory questions, there is a good bit of gray here - be sure to check with your Japanese regulatory experts to make any go/no go decision around localizing your software interface.

Three more to read:

• Japan's Revised PAL: What Device Companies Need to Know
• Effective Translation Process for Japan Regulatory Submissions
• U.S. device manufacturers form Japanese association

If this post was useful, consider subscribing to our Medical Translation Blog via email or RSS.