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U.S. Device Makers Form Japan Group To Speed Approval Process

This article was originally published in PharmAsia News

Executive Summary

U.S. makers of medical devices seeking entry into Japan's market have formed an association to represent and promote member firms in Japan's regulatory process. The 62-member American Medical Devices and Diagnostics Manufacturer's Association plans to lobby for a faster approval process for medical devices. The new association notes that half of the medical devices for which Western makers have sought Japanese approval have yet to be cleared for market. (Click here for more - a subscription may be required
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