Japan implements major changes to its Medical Device registration process

Major Changes to Medical Device Registration Process in Japan (Emergo)
Revised medical device registration and approval requirements in Japan will become law November 25, 2014, and will impact several compliance areas for foreign manufactures active in the market, According to Emergo’s Tokyo office.
Replacing the Pharmaceutical Affairs Law (PAL), the Pharmaceutical and Medical Device Law (PMDL) will affect all major components of Japanese device registration, including in-country representation, quality management system compliance, third-party certifications and regulation of medical software...