What Data Should Be Submitted For Absorbable Hemostatic Products To Prove The Hemostatic Mechanism Of The Product?

The administrative counterpart should submit the technical or supporting data that can effectively prove or explain the principle of hemostasis of the product under application, including but not limited to:

1. The administrative counterpart should elaborate the hemostatic mechanism of the product under application, describe how the product affects the hemostasis process and the advantages of the product in the hemostasis process, and confirm whether the application of the hemostatic mechanism combined with the product under application is scientific and reasonable.
2. The administrative counterpart should conduct a study on whether the product under application may cause adverse reactions related to its use, such as thrombosis and coagulopathy.
3. The administrative counterpart should submit a review of the domestic and foreign research literature supporting the principle of hemostasis, as well as the original and Chinese translations of relevant scientific literature specifically supporting the principle of hemostasis.
4. The administrative counterpart should indicate whether products with the same principle of hemostasis have been marketed at home and abroad.