Feb 5, 2014
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.
Legal reforms affecting medical device regulation in Japan have passed the country’s Diet and are now published in the official Japanese gazette, bringing them closer to full enactment in Asia’s largest single medical device market.
The Japanese Ministry of Health, Labour and Welfare has set a May 2017 compliance date for a revised version of the Japanese Industrial Standard for medical device electrical safety.
The new version, JIS T 0601-1:2012 (IEC 60601-1:2005 modified), replaces JIS T 0601-1:2009 (IEC 60601-1:1998+A1:1993+A2:1995 identical).