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Home » November enforcement date for new pharmaceutical affairs law in Japan

November enforcement date for new pharmaceutical affairs law in Japan

February 7, 2014 By MassDevice Contributors Network

November enforcement date for new pharmaceutical affairs law in Japan

By Stewart Eisenhart, Emergo Group

Japan’s Ministry of Health, Labour and Welfare (MHLW) has set a late November 2014 date to begin enforcing revised regulations (link in Japanese) for medical devices and pharmaceutical products.

The revised Pharmaceutical Affairs Law (PAL), renamed the Pharmaceutical and Medical Device Law, will include more aggressive safety requirements for registered devices and set up distinct Market Authorization Holder (MAH) authorized representative rules for foreign manufacturers.

Sponsored by Emergo Group

Additional enforcement details will be forthcoming from Emergo Group’s Tokyo office.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

Filed Under: Blog, Emerging Markets, News Well, Pharmaceutical, Regulatory/Compliance Tagged With: Emergo Group

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