Core Viewpoint - Shanghai Pudong New Area has introduced regulations to include the after-sale leasing of medical devices into the regulatory framework, marking a significant step in the management of medical equipment financing leasing [1][3]. Group 1: Regulatory Developments - The first management measures, titled "Several Provisions on the Management of Medical Device Financing Leasing in Pudong New Area," will officially take effect on April 25, 2025 [1]. - The regulations aim to clarify the scope of operations for financing leasing companies, expanding it to cover all types of medical devices, not just large medical equipment [2]. Group 2: Industry Needs - There is a pressing need for differentiated management in the medical device financing leasing sector, as current quality management practices do not meet existing regulatory requirements [2]. - Companies are calling for specific regulatory requirements for the after-sale leasing model, which has seen rapid growth but lacks clear compliance guidelines [2]. Group 3: Innovations in Regulation - The regulations will be the first in the country to include after-sale leasing of medical devices under regulatory oversight, establishing specific quality management requirements for this model [3]. - A differentiated management system will be created, allowing financing leasing companies to collaborate with suppliers and users in managing quality across all stages of medical device leasing [3]. - A cross-departmental supervision and inspection mechanism will be established, enabling shared regulatory information between drug supervision and financing leasing management departments [3].