MHLW Outlines Measures To Speed Up Medical Device Approval
This article was originally published in PharmAsia News
Japan's Ministry of Health, Labor and Welfare outlined measures to speed up medical device approval process on its Web page. The measures include tripling the number of current review staff in five years and consolidating human resources on new product reviews. The Ministry plans to increase medical device review staff from currently 35 to 104 by 2013, enhance review staff training programs on the basis of U.S. FDA's training programs and standardize the review procedure manuals. The plan also calls for splitting the current review team into three teams: new devices, improved devices and generic devices, and establish a three track review system. (Click here for more - Japanese language
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