China National Medical Products Administration Clarifies Management Category For Biodegradable Hemostatic Sponges

On December 6, 2023, China National Medical Products Administration’s Comprehensive Department outlined the categorization of Biodegradable Hemostatic Sponges, specifying a shift from Class II to Class III in the management hierarchy.

Product Description: Biodegradable Hemostatic Sponges are composed of polyether-type polyurethane foam, comprising (DL-lactic-co-glycolic acid-co-ε-caprolactone) – polyurethane copolymers, designed for single-use. The product undergoes sterilization through irradiation, ensuring sterility. It is intended for temporary hemostasis and support post nasal, middle ear, and outer ear surgeries.

Biodegradable Composition: The main component of the product, (DL-lactic-co-glycolic acid-co-ε-caprolactone) – polyurethane copolymers, is a material that degrades upon contact with body fluids (such as blood) and the resulting degradation by-products can be absorbed by the human body.

Regulatory Adjustment: Referring to the Medical Device Classification Catalog, similar risk products under the code “14-08-01 Absorbable Surgical Hemostatic Materials,” the product is now categorized as Class III medical devices, with the classification code: 14-08.

Registration Process: Effective immediately, drug regulatory authorities will process product registration applications based on the aforementioned management category.

Transition Period: Products holding a Class II medical device registration certificate as of the announcement date will remain valid until December 31, 2025.

Conversion Requirements: Provincial-level drug regulatory authorities are urged to supervise product registrants in adhering to relevant requirements for the new management category. The conversion of certificates should be actively pursued, with completion targeted by December 31, 2025.

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