If Change Of Permission Items Indicates Adding Of Models, Meanwhile New Standards Are Involved, Does The Original Model Need To Be Implemented With The New Standard Requirements?
2022-09-20
For instance, the registered models are A and B, and the new models are C and D. Then, for the new models, they shall be implemented with the requirements of the new standard, and the testing report and/or verification/validation data shall be provided.
If the original models A and B are not changed, then no relevant information is needed and new standard is not added into the Product Technical Requirements. Administrative counterparts shall ensure that A and B can also meet the requirements of the new standard from the date of implementation of the new standard.
If new standard is added into the Product Technical Requirements, testing reports and/or verification/validation data shall be submitted to certify A and B could meet the modified Product Technical Requirements.
