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www.fdanews.com/articles/168385-devicemakers-face-new-requirements-in-japan-starting-nov-25

Devicemakers Face New Requirements in Japan, Starting Nov. 25

November 7, 2014

With a comprehensive regulatory framework for devices set to take effect on Nov. 25, Japan’s Pharmaceutical and Medical Devices Agency still hasn’t published many of the implementing regulations, leaving industry to guess how best to prepare.
International Medical Device Regulatory Monitor