China News Service, February 23. According to the website of the State Drug Administration, on the 23rd, after review, the State Drug Administration approved the registration and marketing of the extracorporeal cardiopulmonary support auxiliary equipment developed by Jiangsu Saiteng Medical Technology Co., Ltd. with conditions.
This product is the third approved domestic ECMO product.
As an emergency approval product, during the registration application process, the State Food and Drug Administration, in accordance with the principle of "unified command, early intervention, fast, efficient, and scientific approval", has a dedicated person in charge and guides the whole process to ensure that the product is launched and put into use as soon as possible.
According to the article, at present, the overall performance and indicators of the three domestic ECMO products that have been approved have basically reached the level of similar international products. The effective supply guarantee of treatment equipment further meets the needs of treatment and at the same time reduces medical expenses.
In the future, the drug supervision and management department will continue to strengthen the post-market supervision of products to ensure the safety of patients using equipment.
(China New Finance and Economics)
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