NMPA CER Equivalence Assessment for Intracs vs. Fiagon

The requirement for the CER under the NMPA is similar to that of the CER under the CE MDR. To establish equivalence between the Intracs and Fiagon, we need to compare them based on three factors: same intended use, same or similar technical or biological characteristics. Once equivalence is established, we can use the clinical data from Fiagon to support the safety and efficacy of Intracs. However, it has come to my attention that Intracs does not claim equivalence when applying for CE. Therefore, we can only make a rough comparison between the two products. If there are significant differences in design, we can test whether they perform similarly by using some indicators of the PTR. The question now is who will conduct the testing and where it will take place. Your team in Germany has engineers who can conduct the testing, or we can look for a third party in China to do it if you provide the Fiagon.