PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
Japan's regulatory agency responsible for reviewing and approving medical devices and pharmaceuticals. PMDA conducts pre-market reviews (Shonin approval) and post-market safety monitoring for the Japanese market.
The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan's regulatory body for medical devices, pharmaceuticals, and regenerative medical products. PMDA operates under the oversight of the Ministry of Health, Labour and Welfare (MHLW) and is responsible for both pre-market review and post-market safety surveillance.
PMDA approval process
Medical devices in Japan are classified into four categories: General Medical Devices (Class I), Controlled Medical Devices (Class II), Specially Controlled Medical Devices (Class III), and Specially Controlled Medical Devices requiring pre-market approval (Class IV). Class III and IV devices require Shonin (approval) from PMDA, which involves review of safety, efficacy, quality, and manufacturing data. Japan accepts some international clinical data but may require Japanese clinical studies for certain device types.
PMDA in procurement
Japanese hospital tenders require valid PMDA approval (Shonin) or notification as appropriate for the device class. The Japanese market's regulatory requirements, combined with language barriers and unique clinical preferences, make it one of the more challenging markets for international medical device manufacturers to enter.