全市颁出首张跨区“一证（照）多址”医疗器械许可证

Core Viewpoint - The issuance of the first cross-district "one certificate (license) multiple addresses" medical device license in Hangzhou signifies a significant regulatory reform aimed at facilitating the operation of medical device companies across multiple locations within the city [1][2]. Group 1: Regulatory Changes - The new licensing system allows qualified medical device companies to operate in multiple locations within Hangzhou with a single license, reducing the need for separate licenses for each site [1]. - This initiative is part of a broader effort by the government to enhance the business environment and support the development of the life and health industry [1]. Group 2: Operational Efficiency - The regulatory body has established a dedicated service team to assist companies with material submissions and site planning, significantly improving approval efficiency [2]. - Companies can now submit change applications and receive approvals within one working day, streamlining the process [2]. - The new system allows for a unified quality management system across multiple locations, reducing operational costs and enhancing quality control [2]. Group 3: Monitoring and Compliance - The regulatory authority employs smart supervision methods, including remote video inspections, to ensure ongoing compliance and safety of medical devices across all operating sites [2]. - Regular inspections are conducted to maintain the quality and safety standards of medical devices, ensuring that the regulatory framework is upheld [2].