REGULATORY AUTHORITY: 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.

Other Central & East Asia Countries: Afghanistan, India, Japan, Kazakhstan, Kyrgyzstan, Nepal, Russia, South Korea, Sri Lanka, Taiwan, Tajikistan, Uzbekistan