Japan Medical device registration

Freyr provides Japan medical device registration and approval support for device manufacturers that includes registration, classification, MAH and D-MAH agent services for product compliance as per PMDA regulations. Though the market looks promising, the major barrier in obtaining medical device approval in Japan market is the stringent Pharmaceuticals and Medical Devices Agency (PMDA) regulations that companies must abide by. To manage their product registrations and liaise with Japan’s regulatory authorities, all foreign medical device and pharmaceutical companies selling in Japan must assign a licensed Japanese Agent.