T/SHSPTA 008-2025 Guidelines for the Collaborative Operation and Management of Multiple Warehouses for Medical Devices

Scope

Scope: This document stipulates the basic requirements and respective responsibilities of the principal parties, collaborative parties, and entrusting parties during the collaborative operation of multiple warehouses for medical devices, and clarifies the requirements for staffing, facilities and equipment, intelligent supply chain management platforms, logistics management, quality management, and document control during the operation process. This document applies to the operational and quality management activities involved in the cross-regional collaborative operation of multiple warehouses for enterprises providing transportation and storage services to medical device registrants, recorders, and operating enterprises. This document can also serve as a reference for the operational and quality management activities involved in the cross-regional warehouse setup of medical device operating enterprises. Main technical content: - Preface - Introduction - 1 Scope - 2 Normative referenced documents - 3 Terms and definitions - 4 Responsibilities 4.1 Basic requirements 4.2 Principal parties 4.3 Collaborative parties 4.4 Entrusting parties 5 Staffing 6 Facilities and equipment 7 Intelligent supply chain management platforms 8 Logistics management 8.1 Storage management of medical devices in sub-warehouses (zones) 8.2 Selection and configuration management of medical devices 8.3 Transportation management 8.4 Return handling 9 Quality management 9.1 Quality management system 9.2 Access review 9.3 Traceability management 9.4 Risk management 9.5 Complaints 9.6 Adverse events 9.7 Recalls 9.8 Disposal of non-conforming products 9.9 Change management 10 Document control References

Development Information

Related Standards