If a registered product does not apply for renewal registration within the specified time, can the original registered product be selected as the predicate for clinical evaluation when applying for a new registration and how should clinical data be provided?
In this case, the original registered product can be selected as the predicate to complete the clinical evaluation. The comparison of the predicate mainly focuses on whether there is difference between the product under application and the original registered product. If there is no difference, the available clinical data includes the pre-market and post-market clinical data of the product, and the clinical experience data containing the post-market adverse events.
The product is made of material acceptable for clinical use in accordance with Appendix B of YY 0341.1. Whether biological dossiers can be submitted in the way of biological exemption when submitting registration dossiers?
The biological evaluation can’t be exempted. The equivalence comparison can be used to prove that the product under application has the same biocompatibility with the marketed product, so as to determine the reduction or exemption of biological test for the product under application.
For materials conforming to Appendix B of YY 0341.1, equivalence comparison is still required, such as demonstrating whether new biological risks are introduced in the production process and whether the production processes (processing process, sterilization process, packaging, etc.) are the same.
Since the production process may also introduce new harmful substances (residues such as sterilizers, processing AIDS and demoulding agents), if it is evaluated that the production process does not introduce new biological risks, it can be considered to be exempted from biological tests.
