Is It Possible To Add Calibrators Or Controls To The Registration Unit Of The Approved-reagent By Applying For Change Of Permission Items?

For the IVD reagents that do not contain calibrators and controls in the original registration unit, you can apply for the addition of calibrators and/or controls by applying for change of permission items under the following conditions:

1. The added calibrators and/or controls are indeed the ones having been used with the approved reagent in the product evaluation, type examination and clinical application of the approved reagent.
2. After adding calibrators and/or controls, the value traceability of the approved reagent and the quality control method will not change.
3. The manufacturing quality management system at the time of registration of the approved reagents should be able to cover the calibrators and controls to be added.

Relevant supporting documents may include, but are not limited to: evidence that the calibrators and controls are used during reaction system research, performance evaluation, and type examination of the approved reagent; evidence that the manufacturing quality management system of the approved reagent covers the proposed calibrators and controls at the time of original reagent registration; evidence in the original registration dossiers of the IVD reagent that can prove the above situations.

If the evidence mentioned above cannot be submitted, the calibrators and/or controls cannot be added to the registration unit of the approved reagent through the change of permission items.