太仓护航医疗器械产业高质量发展

Core Insights - Jiangsu Province's Taicang Market Supervision Bureau is actively optimizing services to support the development of the medical device industry, addressing new challenges faced by enterprises [1] Group 1: Service Initiatives - The Taicang Market Supervision Bureau has implemented precise and efficient service measures to resolve difficulties in the medical device industry, ensuring smooth project execution [1] - A case example includes Suzhou New Wave Biotechnology Co., which faced challenges in localizing production for 210 products due to tight timelines and tariff policy changes. The bureau provided dedicated support, completing all product registrations in two months, allowing the company to generate an additional annual output value of 20 million yuan [1] Group 2: Collaboration and Efficiency - The bureau collaborated with the provincial drug regulatory authority to enhance the quality and efficiency of review and approval processes, conducting 26 specialized service sessions for enterprises [2] - In 2025, the bureau completed 19 Class I medical device production registrations and 191 product registrations, assisting companies in obtaining 44 Class II and 6 Class III registration certificates [2] Group 3: Project Support - A service "fast track" was established to provide full-cycle support for key projects, with 13 projects receiving comprehensive tracking services since 2025 [2] - The bureau facilitated 6 products entering the national special review channel for innovative medical devices and helped 2 products be included in the Jiangsu Province innovative drug and device product catalog [2] Group 4: Park Services - The Taicang work station of the provincial drug regulatory authority has been pivotal in providing full-chain guidance for enterprises in industrial parks, including product registration and patent transformation [2] - In 2025, nearly 130 services and over 10 specialized training sessions were conducted for enterprises in the parks [2]