For Marketed Animal-derived Dental Biomaterials, If There Are Changes In The Geographical Origins Of Animals, But No Change In The Animal Type, Sampling Site And Tissue Type, And Both The Technical Requirements And Registration Certificate Do Not Reflect The Geographical Origins Of Animals, Is It Necessary To Apply For Change Of Permission Items?

For marketed animal-derived dental biomaterials, if there are changes in the geographical origins of animals, it is suggested to analyze whether the changes in geographical origins substantially affect the safety and effectiveness of the product, for example, the performance equivalence analysis and verification may be conducted for the materials obtained from different origins after treatment. If no effect is generated, the change process may be independently controlled through the change management process under the quality management system of administrative counterpart.