建立专项审批绿色通道 整合多部门职能 优化审批服务

Core Viewpoint - The article emphasizes the need for optimizing the business environment in Shenyang to promote the high-quality development of the medical device industry, particularly focusing on the approval services for medical device consumables [2][3]. Group 1: Approval Optimization Measures - Establish a special approval green channel for consumables, integrating functions from drug supervision, market regulation, and health departments to implement "one-window acceptance, parallel approval, and time-limited completion" for urgently needed and innovative consumables [2]. - Promote a "digital + pre-review service" model to reconstruct the electronic application system for medical device consumables, enabling online submission of application materials, real-time tracking of review progress, and precise push notifications for correction opinions [2]. Group 2: Innovation and Collaboration - Establish a "research-review linkage" mechanism to provide pre-review services such as registration standard interpretation and technical documentation specifications for key enterprises, aiming to reduce application rejection rates and address issues of repeated modifications and multiple corrections [3]. - Suggest the formation of an innovation consortium combining medical and engineering fields to facilitate the integration of production, learning, research, and application, supporting clinical experts and engineers in tackling core technologies and developing prototypes [3].