Case Study 5 : Regulatory, Clinical and Commercial Partners For CE-IVD Device in Japan for IVD

Company Situation

Client’s IVD product was classified as Class III in Japan and required a clinical trial to be done locally. There was no similar product in Japan, that increased the complexity of situation. Considering the strategic importance of Japan as a market, Client needed a partner in Japan who could manage entire go-to-market/commercial strategy, regulatory strategy and support with clinical trials as well as 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. GRP began with accurate classification of the product since the outcomes of the diagnostic offered had relatively higher impact life support, thus classified as Class III. GRP further set up a dedicated team for client including its regional experts with experience in managing entire life-cycle of IVD products.

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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.