Health & Beauty

According to the Huacheng Import and Export Data Observation Report, on February 23, the State Drug Administration approved the registration and listing of the extracorporeal cardiopulmonary support auxiliary equipment developed by Jiangsu Saiteng Medical Technology Co., Ltd. after examination and conditional emergency response. This product is the third approved domestic ECMO product.

As an emergency approval product, during the registration and application process, the State Food and Drug Administration, in accordance with the principle of "unified command, early intervention, rapid and efficient, and scientific approval", has a special person in charge of the whole process of guidance to ensure that the product can be put into use as soon as possible.

The State Food and Drug Administration said that at present, the overall performance and indicators of the three approved domestic ECMO products have basically reached the international level of similar products. The continuous approval and listing of domestic products have improved the accessibility of China's advanced life support equipment, ensured the effective supply of COVID-19 critical treatment equipment, further met the treatment needs, and also reduced medical expenses. Subsequently, the drug supervision and administration department will continue to strengthen the post-marketing supervision of products to ensure the safety of patients' equipment. Huacheng Import and Export Data Observation Report.

Data shows that ECMO, extracorporeal membrane oxygenation, is also known as artificial heart-lung machine.

According to the report of Huacheng Import and Export Data Observation, on January 4, 2023, the State Food and Drug Administration approved the application for registration of extracorporeal cardiopulmonary support auxiliary equipment and disposable membrane oxygenator package of Shenzhen Hannuo Medical Technology Co., Ltd. after review, and the two were used in combination for adult patients with acute respiratory failure or acute cardiopulmonary failure, other treatment methods are difficult to control, and there is a foreseeable risk of continuous deterioration or death. As the first domestic ECMO equipment and consumables package, the above products have independent intellectual property rights, and their performance indicators basically reach the international level of similar products.

On January 17, the State Food and Drug Administration approved the registration and listing of extracorporeal lung support assistive equipment developed by Aerospace New Long March Medical Instruments (Beijing) Co., Ltd. by means of conditional approval after review. This product is the second approved domestic ECMO product. This product provides power and safety monitoring during cardiopulmonary bypass, and is used in combination with compatible disposable consumables to achieve auxiliary support of lung function. This product is applicable to adult patients with acute respiratory failure and other treatment methods that are difficult to control and have a foreseeable risk of continuous deterioration or death. Huacheng Import and Export Data Observation Report.