For Animal-derived Dental Biomaterials, If The Sterilization Method Is Changed, Can The Method Be Added Or Changed Through The Procedures For Change Of Permission Items?

The sterilization method can be added or changed through the procedures for change of permission items. In case of any change in the sterilization method of animal-derived dental biomaterials, it is necessary to submit at least the sterilization effectiveness verification report and the product shelf life verification report, and to confirm whether the change in sterilization method has any influence on the safety and effectiveness of the product. If the product performance is affected by sterilization, it should be re-verified. If the sterilization process is used as the process of virus inactivation, the change in sterilization method requires re-verification of virus inactivation; if the sterilization process is not used as the process of virus inactivation, it is not necessary to re-verify virus inactivation.