ME Consulting, Japan's Medical Device Regulatory Application, Japan's Medical Device Regulatory Consulting, Medical Device Business Consulting in Japan [NEWS]

Basic Information ;

	Japan's new third party certification system for medical devices (Class II) The revised PAL introduced a third party certification system for pre-market approval of "designated controlled medical devices" (Class II) for certifying conformity by an accredited third party certification body registered by the MHLW.

	Revisions to Japan's Pharmaceutical Affairs Law for Medical Devices (Update 1) [PDF : 35kb] This report highlights important points to be noted by foreign medical device manufacturers for import and marketing authorization of medical devices under the recent revisions of the Pharmaceutical Affairs Law (PAL) in Japan.
The revisions of the PAL encompass significant changes in regulatory requirements for marketing authorization of medical devices in Japan by foreign manufacturers. It will be increasingly important to develop regulatory strategy as well as business strategy for the entry to the Japanese medical device market. ME Consulting Co.,Ltd, based in Tokyo, is a medical device regulatory consulting firm that helps international medical device manufacturers with regulatory strategy development and business consulting for the Japanese medical device market.