Recently, Shandong Jiuzhoutong Pharmaceutical Co., Ltd. obtained approval for multi-warehouse collaborative medical device operations, becoming the first enterprise in Jinan High-Tech Zone to receive this qualification since the formal implementation of the "Shandong Province Medical Device Multi-Warehouse Collaborative Operation Supervision and Management Measures." This achievement reflects Jinan High-Tech Zone's commitment to implementing industrial development policies and supporting regional pharmaceutical supply chain advancement. It also marks a significant breakthrough in supply chain innovation for the zone's medical distribution sector.
As an advanced model in China's medical distribution industry, multi-warehouse collaborative operations integrate storage and transportation resources of medical device enterprises across the province, enabling coordinated procurement, inspection, storage, and transportation activities. This model establishes a unified "central warehouse + collaborative warehouse" network, breaking the limitations of traditional "single-warehouse nationwide distribution." It achieves centralized resource allocation, unified procurement, and decentralized distribution, significantly improving logistics efficiency and providing strong support for optimizing medical device circulation.
The approval process for multi-warehouse collaborative operations involves complex documentation reviews and requires cross-regional coordination with regulatory authorities for on-site inspections, posing significant challenges in terms of coordination and time. Jinan High-Tech Zone's Approval Service Department tailored a full-process service plan to efficiently address these hurdles, ensuring smooth approval.
**Pre-Review and Risk Mitigation** The department proactively guided enterprises in clarifying quality responsibility boundaries between lead entities and collaborative warehouses, particularly for Jiuzhoutong's eight-city distribution network. Detailed refinement of application materials laid a solid foundation for qualification approval.
**Regulatory Coordination and Risk Control** Adhering to the principle of "risk prevention throughout the process," the department rigorously reviewed key aspects such as quality management systems, traceability IT systems, temperature-controlled storage, and emergency response capabilities. The "strict entry + dynamic supervision" approach balances operational innovation with quality and safety compliance.
**Streamlined Services for Efficiency** Expanding "fully online + paperless" services, the department enabled pre-review and instant feedback for applications, minimizing corporate effort. Post-approval, enterprises can choose between on-site collection or mailed licenses, reducing institutional costs and enhancing satisfaction.
Moving forward, Jinan High-Tech Zone will continue to focus on core enterprise needs, deepen approval service reforms, and promote advanced models like multi-warehouse collaboration while upholding safety standards. This initiative aims to elevate medical device enterprises' quality management and market competitiveness, driving high-quality regional industry growth.