9185a618_Registration___Shonin_Approval__Required_for_Class_II_Devices__Required_for_Class_II_Devices
[Section] 4
Description of the medical device: General information Evidence that raw materials are the same with exiting products/Specification of raw materials/sterilization method Explanation of new raw materials for its effectiveness and safety using test results Basis for setting up product specifications Comparison with an already approved product to show sameness
Japan Medical Device Registration - Shonin Approval
Information Required for Class II Devices