Comments on the Guidelines for Review of Registration Changes of In Vitro Diagnostic Reagents (Draft for Comments)

2023-06-30 | Beijing

On June 30th, the Consumerable and Disposable Medical Device Desk provided feedback to the National Center for Medical Device Evaluation concerning the Guidelines for Review of Registration Changes of In Vitro Diagnostic Reagents (Draft for Comments).

The main points include adding clauses to the registration of in vitro diagnostic reagents that do not require verification and confirmation, in order to prevent repeated applications for the same matter. If risks can be directly determined without increased risks, a risk analysis report for changes may not be needed. Similar to medical devices, a process for notifying changes in the instructions or change records should be established. If the change causes potential or possible risks that do not affect clinical performance, non-clinical studies can confirm that potential/possible risks can be mitigated and the remaining risks are acceptable, and clinical evaluation is not necessary.