WASHINGTON (Kyodo) The time Japan takes to approve medical devices is longer than elsewhere and could have detrimental effects on U.S. manufacturers, the U.S. International Trade Commission said Wednesday.
While noting there is “no evidence of discrimination” against foreign products in Japan’s medical equipment market, the ITC said U.S. firms “may be disproportionately affected” in their sales, exports and profitability by the “much longer” approval times.
Innovative medical devices, in which U.S. makers have a competitive advantage, face approval times of up to three years in Japan, although they have much shorter life cycles — about 18 months — than other products, the semijudicial agency that enforces U.S. trade laws said in a report.
“Thus, industry officials contend that delays in regulatory approvals in Japan result in significant opportunity costs for U.S. medical device firms during the time their products are undergoing review,” the report said.
The report was compiled in response to a request for a probe filed with the ITC by the House of Representatives Ways and Means Committee. The request reflects the U.S. medical device industry’s long-standing call for improvement in Japan’s regulatory approval procedures.
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