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Japan Takes Longest to Approve New Devices, Report Finds

How confusing is Japan's premarket approval system? CDRH official Larry Kessler, chair of the Global Harmonization Task Force, used that word to describe it at last week's AAMI/FDA annual conference. And if there's anyone from outside Japan who you'd think would understand its premarket approval system, it'd be the GHTF chair. That notion has been reinforced in a report by the U.S. International Trade Commission.

It found that approval times in Japan were longer than those in other principal global markets. As the leader in developing and exporting innovative medical technologies, the United States may be disproportionately affected by this. Even though reform was enacted in 2005, significant challenges remain, especially for small and mid-sized businesses, the report states. And if the GHTF chair can't succinctly explain how Japan's approval system works, don't expect them to be overcome any time soon.

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