In August 2025, the National Medical Products Administration approved the launch of the third domestically produced ethyl silicone oil based medical catheter, marking an important breakthrough in China's high-end medical device materials field. Data shows that by 2025, the market size of medical grade ethyl silicone oil in China will reach 820 million yuan, with a compound annual growth rate of 41.7%, and the import substitution rate will increase from 12% in 2018 to 40%.
Technological breakthrough: solving the problem of biocompatibility
Medical grade ethyl silicone oil must meet strict biocompatibility standards. The "Ultra Pure Ethyl Silicone Oil Synthesis Process" developed by Guangzhou Baiyun Medical Silicone Rubber Research Institute after 5 years of research and development has successfully applied to three types of medical devices, including scar patches and urinary catheters, by controlling the impurity content below 10ppm through molecular distillation technology. This technology has been authorized to enterprises such as Shandong Dongyue Group, promoting a 35% reduction in domestic product prices compared to imported products.
Clinical application: covering multiple departmental scenarios
In the cardiovascular field, ethyl silicone oil coated catheters can reduce the risk of thrombosis and have entered the procurement catalog of more than 200 tertiary hospitals; In tumor treatment, drug loaded silicone oil microspheres achieve targeted delivery, reducing chemotherapy side effects by 50%. In addition, the "Intelligent Temperature Controlled Silicone Oil Catheter" developed by Shenzhen Mindray Medical, which adjusts the drug release rate by real-time monitoring of tissue temperature, won the 2025 German Red Dot Design Award.
Policy dividend: Accelerating approval to promote industrialization
In 2024, the National Medical Products Administration released the "Technical Guidelines for Medical Organosilicon Materials" to simplify the approval process for innovative products. Driven by this, a total of 7 ethyl silicone oil based medical devices were approved in the first half of 2025, an increase of 200% compared to the same period last year. Jiangsu Yuyue Medical invested 500 million yuan to build the "Medical Silicon Material R&D Center", which is expected to launch the first biodegradable silicone oil stent in 2026.
