Case Study 162: Registration of Class III Surgical Implant Medical Device in Japan

Company Situation

A German medical device company that is the world’s leading developer of textile surgical implants, was looking for a local partner in Japan who can register its implants with PMDA in Japan. The implants are Class III devices that are intended for the surgical treatment of inguinal or femoral hernias and permanently bridges and reinforces the soft tissue in the groin region in the area of the hernia defect.

GRP Solution

GRP Regulatory Affairs team has many years of experience registering Class III and Class IV medical devices in Japan.

GRP RA team provided the following services:

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