NMPA Upgrades Regulatory Classification Of Degradable Expandable Hemostatic Sponge Products

NMPA released information on December 4^th to upgrade the classification of Degradable Expandable Hemostatic Sponge Products from Class II to Class III.

In an effort to clarify the management attributes and categories of Degradable Expandable Hemostatic Sponge products, the National Medical Products Administration has released a notice outlining key considerations. The following details are now officially communicated:

1. Product Description:
   • The “Degradable Expandable Hemostatic Sponge” is composed of polyether-type polyurethane foam, consisting of (DL-lactide-co-ε-caprolactone) – urethane copolymer, and is intended for single-use.
   • The product undergoes sterilization through irradiation and is expected to be sterile. It is specifically designed for temporary hemostasis and support in postoperative procedures involving the nasal cavity, middle ear, and outer ear.
2. Composition and Classification:
   • Based on current scientific understanding, the component (DL-lactide-co-ε-caprolactone) – urethane copolymer in the product is a material that degrades upon contact with bodily fluids, such as blood, with degradation by-products absorbable by the human body.
   • Following the classification of similar risk products in the “Medical Device Classification Catalog” under “14-08-01 Absorbable Surgical Hemostatic Materials,” this product falls under the management of Class III medical devices, with the assigned code: 14-08.
3. Regulatory Procedures:
   • Effective from the date of this notice, drug supervision and administration departments will accept product registration applications in accordance with the specified management category.
4. Transition for Previously Registered Products:
   • For products that obtained Class II medical device registration certificates before the release of this notice, the original Class II registration certificates will remain valid until December 31, 2025.
   • Provincial drug supervision and administration departments are urged to oversee product registrants to actively initiate the certificate transition process, adhering to the relevant requirements of the new management category, and ensure completion before December 31, 2025.
   • Registrants are also encouraged to fulfill their responsibilities for product quality and safety, ensuring the security and effectiveness of marketed products.

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