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Third China domestic ECMO products approved for marketing

CCFDIE|Updated: 2023-02-23

     

On February 23, 2023, the Extracorporeal Membrane Oxygenation auxiliary device and centrifugal pump head of Jiangsu STMed Technology Inc. is approved with conditions through emergency review by China NMPA. This product is the third domestic ECMO product granted approval.

During the registration and application process of this product, the NMPA in accordance with the principle of "unified command, early intervention, fast and efficient, and scientific review and approval", with specific person in charge, giving guidance during the whole process, ensures the marketing and application of this product under emergency review as soon as possible.

At present, the overall performance of those three domestic ECMO devices approved are on par with international standards of similar products. The constant marketing of China's domestic products increases the accessibility of advanced life support equipment, ensures the effective supply of devices for treating severe cases of COVID-19, which better meets the need for treatment, and in the meanwhile lowers the medical expenses.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.