Slow Japanese Regulatory Process Affects U.S. Firms

According to a new report by the U.S. International Trade Commission (ITC), slow approval times for medical devices in Japan could negatively affect U.S. firms. And according to the report, Medical Devices and Equipment: Competitive Conditions Affecting U.S. Trade in Japan and Other Principal Foreign Markets, the more innovative the firm, the deeper felt Japan’s lag time: An ITC press release explains, “U.S. medical device firms are the world’s leading developers and exporters of high-technology medical devices… Although the Japanese approval system does not discriminate in its treatment of domestic and foreign-made medical devices, medical device firms that specialize in innovative products are more adversely affected by the regulatory delays and other unique costs of the Japanese approval system because of the shorter product life cycles ( as short as 18 months ) and more rigorous regulatory scrutiny of such products compared to less advanced medical technologies. The Japanese regulatory environment is also particularly difficult for small and medium size firms.” No surprise then, “Recent data indicate that U.S. firms are submitting significantly fewer products for approval in Japan,” reports ITC.

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