Case Study 20 : Regulatory Intelligence Report on New Medical Device Market Access to Japan

Company Situation

Client had a novel technology induced medical devices which they wanted to launch in Japan. They wanted support regarding the category and the registration process for such products.

GRP Solution

GRP acted as their partners to identify the category and the relevant registration pathway and provided all the information in the form of a report which covered the following activities:

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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.