In September 2025, significant progress was made in the application of ethyl silicone oil in the field of biomedicine, and medical grade products developed by domestic enterprises passed FDA certification for the first time, achieving mass export to European and American markets. This breakthrough marks the extension of China's organic silicon materials from the industrial sector to the high value-added medical market.


Technological breakthroughs to solve authentication problems
Biomedical materials must meet strict requirements for biocompatibility and chemical stability. Traditional ethyl silicone oil is difficult to pass medical certification due to excessive residual catalysts and small molecule impurities. In 2025, a certain enterprise successfully obtained ISO 10993 biosafety certification by using a combined process of "molecular distillation+supercritical extraction" to increase product purity to 99.99% and heavy metal content below 0.1ppm. Another company has developed a "two-step" vulcanization technology, which makes silicone products odorless and free of precipitates, meeting the standards for implantable medical devices.


Continuous expansion of clinical application scenarios
Technological breakthroughs have promoted the widespread application of ethyl silicone oil in the medical field. In surgical procedures, a hemostatic silicone oil developed by a certain company can physically adsorb and seal capillaries, reducing surgical bleeding by 40%; In the field of drug delivery, silicone oil microspheres as sustained-release carriers can extend the drug release cycle from 24 hours to 30 days, improving patient compliance. In addition, products such as silicone oil based artificial lenses and corneal contact lens lubricants have also entered the clinical trial stage and are expected to be launched in 2026.


Increased recognition in the international market
Domestic medical silicone oil gradually replaces imported products with its cost-effectiveness advantage. In 2025, a certain enterprise signed a long-term supply agreement with a German medical device company to provide silicone raw materials for cardiac occluders; Another company has become a supplier of artificial tear silicone oil for a certain ophthalmic giant in the United States. According to customs data, in the first half of 2025, the export volume of medical silicone oil in China increased by 60% year-on-year, with a unit price 30% lower than imported products, significantly enhancing competitiveness.


The industry standard system is gradually improving
To standardize market development, industry associations are promoting the development of group standards for "Medical Silicone Oil", clarifying key indicators such as purity and impurity limits. In 2025, a certain national drug regulatory agency will include silicon-based medical devices in the priority review channel, shortening the approval cycle from 12 months to 6 months. Experts believe that with the improvement of the regulatory system, the medical silicone oil market will maintain an average annual growth rate of 15%, and the market size is expected to exceed 5 billion yuan by 2027.