ABSTRACT
The Pharmaceutical Affairs Law (PAL) establishes the requirements for medical device labeling in Japan. The PAL sets the minimum required information that must be included in the labeling on the device, on its immediate container, and in the package insert. The requirements in the PAL are amplified in the Enforcement Regulations of the Pharmaceutical Affairs Law (ERPALs), and in performance and approval standards adopted by the Ministry of Health, Labor, and Welfare (MHLW).
MISBRANDING
