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