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高淳医疗器械产业园区一季度新增4个Ⅲ类证、29个Ⅱ类证
Xin Hua Ri Bao· 2025-04-26 23:26
Group 1 - The core viewpoint of the articles highlights the growth and innovation in the medical device industry in Nanjing, particularly in the Gaochun District, where companies are successfully obtaining medical device registration certificates, indicating a robust development environment [1][2][3] - Nanjing Youdebang Medical Technology Co., Ltd. has received approval for its peripheral balloon dilation catheter, adding to its existing portfolio of 6 Class II and 14 Class III products, with over 10 more in development [1] - The Gaochun District has seen a significant increase in medical device registrations, with 4 new Class III and 29 Class II certificates issued in the first quarter, totaling 347 Class II and 33 Class III certificates by the end of March [1] - The collaboration between the Jiangsu Provincial Drug Administration and the Gaochun District government has fostered the establishment of a medical device industrial park, focusing on high-value consumables, in vitro diagnostics, and rehabilitation medical devices [1] - Nanjing Deven Medical Technology Co., Ltd. has achieved annual sales exceeding 80 million yuan with its main product, a microwave ablation needle, and expects to obtain 7 more registration certificates this year [1][2] Group 2 - The innovation strength of companies in the medical device sector is underscored by significant R&D investments, with Nanjing Deven investing 20 million yuan in new product development last year [2] - The Gaochun District is developing a public service platform for the medical device industry, which aims to enhance the efficiency of the entire industry chain [2] - Nanjing Youwei Medical Technology Co., Ltd. has successfully developed a nasal stent that has become the first innovative medical device product approved in Gaochun, significantly reducing the time for application and review processes [2] - The medical device production sector in the Gaochun District has grown to include 193 companies, with a reported revenue growth of 15% year-on-year [3] - The management office of the Nanjing Medical Device Industrial Park aims to sign 20 new projects and add 90 new medical device registration certificates this year [3]