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时间:2023-3-20 15:53:51来源:本站原创作者:佚名点击:

According to the COVID-19 prevention and control needs, in order to ensure the treatment of severe COVID-19 patients, the National Medical Products Administration of China (NMPA) urgently approved the registration applications of the extracorporeal membrane oxygenation (ECMO) equipment and the membrane oxygenator package for single use of Chinabridge (Shenzhen) Medical Technology Co., Ltd. on January 4, 2023 after review, with the two to be used in combination in adult patients who have acute respiratory failure or acute cardiopulmonary failure that is difficult to be controlled with other treatment methods and have a predictable risk of continued deterioration or death. The above products, as the first domestically developed ECMO equipment and consumables package, have independent intellectual property rights, with performance indicators basically reaching the levels of similar products in the world.

Among them, the ECMO equipment consists of the main machine, pump drive, emergency pump drive, backup battery, flow-bubble sensor, etc., and the membrane oxygenator package for single use consists of the membrane oxygenator, arteriovenous pipeline assembly (including the centrifugal pump head), pre-filled pipeline assembly, accessory kit assembly and oxygen pipeline.

As a salvage therapeutic device for severe COVID-19 patients who fail conventional treatment, the ECMO product is a therapeutic measure defined in theDiagnosis and Treatment Protocol for COVID-19. The marketing of this domestically developed product will play an important role in meeting urgent clinical needs, supporting the treatment of severe COVID-19 patients and ensuring the achievement of the COVID-19 prevention and control goals of “caring for health and preventing severe cases”.

In the registration application process of the product, according to the principles of “unified command, intervention at the early stage, high efficiency and scientific approval”, the NMPA set up an emergency review working group, assigned dedicated personnel to take charge, provided whole-process guidance and issued guiding principles for technical review to increase guidance on the product registration application and accelerate the review and approval process. On the basis of ensuring safety and effectiveness, the NMPA promoted the marketing of the product as soon as possible, to meet the urgent needs of the COVID-19 prevention and control work.

Medical products administrations will strengthen the post-marketing regulation of the product, so as to protect the safety of patients in using the medical device.

Source: CNDAnews

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