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www.fdanews.com/articles/113770-japanese-regulators-strive-to-close-8216-device-gap-8217

Japanese Regulators Strive to Close ‘Device Gap’

January 15, 2009
The plan, set to take effect April 1, calls for an increase in the number of medical device reviewers and introduces a three-track system — new products, improved products and copycat products.
Devices & Diagnostics Letter