Recently, the State Food and Drug Administration issued the "Appendix to the Medical Device Business Quality Management Standards: Enterprise Quality Management Specialized in Provide Medical Device Transportation and Storage Services" (hereinafter referred to as the "Appendix"), which standardizes the enterprise quality management , which specializes in providing medical device transportation and storage services (commonly known as "third-party logistics"), to ensure the quality and safety of medical devices in the transportation and storage links, and promote the high-quality development of the medical device logistics industry. The Appendix will come into effect on January 1, 2023.
"Appendix" is a special requirement for enterprise business quality management specifications that specialize in providing medical device transportation and storage services. The operating quality management system of such enterprises shall comply with the requirements of " Medical Device Business Quality Management Standards " and "Appendix".
"Appendix" puts forward specific requirements for enterprises that specialize in providing medical device transportation and storage services from the aspects of quality management system establishment and improvement, institutions and personnel, facilities and equipment, computer information systems, and quality responsibilities. On the basis of ensuring the quality and safety of medical devices and controllable risks, the Appendix encourages enterprises to make full use of new technologies such as informatization, digitalization and the Internet, and the Internet of Things in the modern logistics industry, promote the implementation of unique medical devices, and promote the traceability of medical devices throughout the process. Encourage enterprises to develop intensively, integrate and digitally, adopt new technologies to develop modern logistics, and improve medical device supply guarantee service capabilities.
