Medical-Grade Silicone Demand Rises 25% YoY; ISO 13485 Certif

Keywords: Medical-grade silicone, ISO 13485, medical devices, biocompatibility, Hongye Silicone Summary: Global demand for medical-grade silicone rose 25% YoY in Q1 2026; ISO 13485 certification is now a mandatory requirement for medical device manufacturers. Details: Industry data shows medical-grade silicone demand reached 35,000 tons in Q1 2026, up 25% YoY, driven by growth in implantable devices, catheters, wound dressings, and prosthetics. Strict biocompatibility and safety requirements have made ISO 13485 certification standard for suppliers. High-purity LSR (low-cyclic, platinum-cured) dominates the market, commanding 30%–40% premiums. Hongye Silicone’s medical-grade silicone lines are ISO 13485-certified, meeting FDA and EU medical device standards.