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Second China domestic ECMO products approved for marketing

CCFDIE| Updated: 2023-01-17

On January 17, 2023, the Extracorporeal Membrane Oxygenation auxiliary device of RocketMedical Co., Ltd. (Rocket Medical) is approved with conditions through emergency review by China NMPA. This product is the second domestic ECMO product granted approval. The product provides power and safety monitoring during extracorporeal circulation, and is used in combination with compatible disposable consumables for pulmonary support. The product is intended for adult patients with acute respiratory failure that is difficult to control by other treatments and where there is a foreseeable risk of continued deterioration or death.

The product is composed of Revive-I ECMO, flow/bubble sensor, emergency drive, emergency drive holder, pressure connection cable, oxygenator holder, medical gas holder and cart.

The marketing of the product will further improve China's ECMO product supply capacity, meet clinical needs, improve treatment of severe cases of COVID-19, and better implement the goal of "protecting health and preventing severe diseases" of COVID-19 prevention and control.

During the registration and application process of this product, the NMPA establishes an emergency review task force, 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, releases technical review guidelines, increases the guidance of product registration and application, and accelerates the review and approval process.

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