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 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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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.