Case Study 21 : Regulatory Strategy & Registration of Otometric Devices in Japan

Company Situation

The Client is a European medical device company, leader in the design and manufacture of otoscopes and audiometric products.

GRP Solution

GRP was right partner for client due to its local presence and tremendous experience of its experts in registering devices for otology as well as importation and ensuring safety and compliance of device as per Japanese regulations.

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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.