What Data Should be Submitted to Prove the Hemostatic Mechanism of Absorbable Hemostatic Products in China?

In order to prove the hemostatic mechanism of absorbable hemostatic products in China the applicant must submit technical or supporting data that can effectively prove or explain the principle of hemostatic action of the declared product.

It must:

• clarify the hemostatic mechanism of the declared product in detail,
• describe how the product affects the hemostatic process,
• the advantages of the product in the hemostatic process, and
• confirm whether the application of this hemostatic mechanism combined with the declared product is scientific and reasonable.

The applicant must review the domestic and foreign research literature supporting the hemostasis principle, and submit the original text and Chinese translation of the relevant scientific literature specifically supporting the hemostasis principle. The applicant must also clarify whether there are products applying the same hemostasis principle on the domestic and foreign markets, and also study whether the declared product may cause thrombosis, coagulation disorders, and other adverse reactions related to its use.