Case Study 4: Regulatory Strategy & Registration of Otometric Devices in Japan for a European Device Manufacturer

Company Situation

Client was new to Japan market and needed end to end support right from strategy, product registration, legal representation, marketing authorization holder in country, custom clearance, distributor identification and post approval maintenance of product in Japan. Client did not want to invest initially in registering the company and employing staff, instead it was seeking a reliable partner to work with its distributors to ensure its global ISO standards of product quality in the market.

GRP Solution

GRP was right partner for client due to it 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. GRP set up a specialized team at its regional office in Tokyo, that managed client’s products right from pre-submission consultation, registration, importation and post approval safety assessment/adverse events reporting. GRP continues to act as trusted partner for client to continue to expand its business interests in the region. GRP had provided a detailed process involving all the steps in acquiring the approval, potential bottlenecks & remediation as well a comprehensive documentation roadmap to ensure seamless registration and safety reporting. GRP’s expertise in Japanese language enabled seamless interaction with different stakeholders through the lifecycle.

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