Case Study 22 : Regulatory, Clinical & Commercial Support for IVD Company in Japan

Company Situation

The Client is US in-vitro medical device company that wanted to register its IVD in Japan that is Class III device. There was no similar device in Japan, the conduct of a local clinical study was requested by PMDA. Considering the strategic importance of Japan as a market, Client needed a partner in Japan who could manage the entire process, define regulatory strategy, conduct clinical trial in Japan, perform product registration, perform pharmacovigilance and post-market surveillance activities owning complete responsibilities to ensure regulatory and commercial success.

GRP Solution

GRP understands the complexity Japan as a market can present, not just in terms of complex regulations, the complex market structure as well as language as a barrier to entry. These challenges present bottlenecks at every step of product commercialization and post marketing.

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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.