Case Study 18 : Regulatory Strategy & Registration of medical devices in Japan

Company Situation

Client was new to Japan market and needed end to end support right from strategy, product registration, legal representation, marketing authorization holder in country, custom clearance, distributor identification and post-approval maintenance of product in Japan.

GRP Solution

GRP was right partner for client due to its local presence and tremendous experience of its experts in registering devices ensuring safety and compliance of device as per Japanese regulations. GRP Acted as an in-Country D-MAH, supported with preparation of registration dossier and reimbursement for product.

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Aerial view of Tokyo cityscape with Fuji mountain in Japan, Tokyo

Japan's PMDA

In Japan, The Pharmaceuticals and Medical Devices Agency (PMDA) is the government organization in charge of reviewing drugs and medical devices, overseeing post-market safety, and providing relief for adverse health effects. The PMDA operates under the Ministry of Health, Labor, and Welfare (MHLW) .These two government organization both handle a wide range of activities, from approval reviews to post-market surveillance.