Medical-Grade Silicone Localization Accelerates; 2026 Certif

 

Keywords: Medical-grade silicone, localization, GMP, ISO 13485, Hongye Silicone Summary: China’s medical-grade silicone capacity is set to double in 2026 as domestic manufacturers expand GMP/ISO 13485 lines, cutting import reliance from 65% to below 40%.

Details: Driven by Made in China 2025 policies and medical device reform, domestic medical-grade silicone capacity is expanding rapidly. Certified capacity reached 40,000 tons in 2024, with import dependence at 65%. By 2026, certified capacity is expected to double to 80,000 tons, reducing import reliance to under 40%. Domestic products cost 30%–40% less than imported equivalents, aiding cost control for catheters, implants, and wound care. Hongye Silicone is advancing medical-grade LSR and biocompatible silicone R&D, targeting ISO 13485 certification by late 2026 to serve global medical clients.