: Medical devices are regulated by the Pharmaceuticals and Medical Devices Agency (PMDA), under the Ministry of Health, Labour and Welfare (MHLW). CLASSIFICATION SYSTEM:
Devices are classified according to risk into Classes I, II, III and IV. TIMEFRAME:
The registration process ranges from 8-16 months, depending on classification. LICENSE VALIDITY:
Licenses issued in Japan expire after five years. AUTHORIZED REPRESENTATIVE:
An authorized representative is required. ADDITIONAL INFORMATION:
An application of Foreign Manufacturers Accreditation (FMA) is required in addition to the product license.
Last updated on February 9 2015.
ARE YOU INTERESTED IN REGISTRATION IN JAPAN? REQUEST A FREE QUOTE>