Home> Medical Devices

China Domestic ECMO products approved for marketing

CCFDIE| Updated: 2023-01-05

On January 4, 2023, the Extracorporeal Membrane Oxygenation System Console and its matching disposable kit of Chinabridge (Shenzhen) Medical Technology Co., Ltd. are approved through emergency review by China NMPA, to ensure the treatment needs of patients with severe cases of COVID-19 infection according to the demands of epidemic prevention and control. The system and disposable kit are used together for acute respiratory failure, acute cardiopulmonary failure or no other effective treatment methods for adult patients who have a foreseeable risk of continuous deterioration or death. As the first domestic ECMO system and disposable kit, the above products have independent intellectual property rights, and the devices’ performance is on par with international level of similar products.

The Extracorporeal Membrane Oxygenation System is composed of a console, pumpdriver, an emergency pumpdriver, batteries, flow and bubble sensor, etc. The disposable kit consists of a centrifugal pumphead, a membrane oxygenator and 3x integrated pressure sensors all pre-connected with medical grade tubing along with a priming kit, oxygen tubing and other accessories. 

As a rescue treatment device for patients with severe SARS-CoV-2 infection who failed to respond to conventional treatment, ECMO is the treatment measure specified in the diagnosis and treatment plan for the novel coronavirus disease (COVID-19). The launch of domestic products will play an important role in meeting clinical needs, ensuring the treatment of patients with cases of COVID-19, and ensuring the implementation of the goal of "to protect public health and prevent severe cases" for epidemic 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 special person in charge, giving guidance during the whole process of guidance, releases technical review guidelines, increases the guidance of product registration and application, accelerates the review and approval process, and promotes the product to be marketed as soon as possible on the premise of ensuring safety and effectiveness, to meet the urgent needs of epidemic prevention and control.

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