济南国际医学中心精准服务企业,助力医疗器械注册提速增效

Core Viewpoint - The Jinan International Medical Center is actively facilitating communication between medical device companies and regulatory bodies to streamline the registration process for medical devices [1][3]. Group 1: Event Overview - The Jinan International Medical Center organized a special guidance consultation activity for six medical device companies at the Shandong Provincial Food and Drug Review and Inspection Center [1]. - Following the initial consultation, some companies engaged in discussions regarding product testing technical issues at the Shandong Provincial Medical Device and Drug Packaging Inspection Research Institute [1]. Group 2: Expert Guidance - Experts from the Shandong Provincial Food and Drug Review and Inspection Center provided detailed guidance on key and challenging issues in the medical device registration process [3]. - Company representatives raised specific questions related to registration documentation, product technical requirements, clinical trials, and verification processes, which were addressed by the experts with practical suggestions [3]. Group 3: Impact on Companies - The face-to-face communication helped companies resolve many registration-related confusions and deepened their understanding of relevant policies, regulations, and review requirements [3]. - The Medical Center's committee is committed to optimizing the business environment in the region by providing precise and personalized services to enterprises [3]. Group 4: Regulatory Support - The Provincial Drug Administration has established a "review and inspection linkage" service channel to enhance support for innovative device applications [3]. - The organization of this special guidance consultation activity exemplifies the committee's commitment to providing precise services to companies, effectively shortening the registration process and boosting the development vitality of medical device enterprises in the region [3].