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.
Additional enforcement details will be forthcoming from Emergo Group’s Tokyo office.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.