Release date: 2023.12.06
In order to further clarify the management attributes and categories of “degradable expandable hemostatic sponge” products, the China NMPA notice as follows:
1. “degradable expanding hemostatic sponge” products are polyether-type polyurethane sponges, which are composed of (DL-lactide-co-ε-caprolactone)-urethane copolymer and are disposable. Products have been sterilized by irradiation and should be sterile. It is used for temporary compression, hemostasis and support after nasal cavity, middle ear and external ear surgery. Based on current scientific understanding, the component of this product (DL-lactide-co-ε-caprolactone)-urethane copolymer is a kind of product that can be degraded after contact with body fluids (such as blood), and the degradation products Materials that can be absorbed by the human body. Referring to the management attributes and categories of similar risk products “14-08-01 Absorbable Surgical Hemostatic Materials” in the “Medical Device Classification Catalog”, this product should be managed according to the third category of medical devices, classification code: 14-08. From the date of issuance of this notice, the drug regulatory department will accept product registration applications according to the above management categories.
2. For those who have obtained the Class II medical device registration certificate before the date of this notice, the original Class II medical device registration certificate will continue to be valid before December 31, 2025. Provincial drug regulatory authorities urge registrants of such products to actively carry out the conversion of registration certificates in accordance with the relevant requirements of the corresponding management categories and complete the conversion before December 31, 2025; urge relevant registrants to effectively implement the main responsibility for product quality and safety, Ensure the safety and effectiveness of marketed products.