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According to the "China Medicine News" public account, on October 31, the State Food and Drug Administration issued the "Appendix to the Good Management Practice for Medical Devices: Quality Management of Enterprises Specializing in Providing Medical Device Transportation and Storage Services" (hereinafter referred to as the "Appendix"), which standardizes the quality management of enterprises specializing in providing medical device transportation and storage services (commonly known as "third-party logistics"), ensures the quality and safety of medical devices in transportation and storage, and promotes the high-quality development of
the medical device logistics industry.
The Appendix will come into force
on January 1, 2023.
the medical device logistics industry.
The Appendix will come into force
on January 1, 2023.
The Appendix is a special requirement
for the operation quality management practices of enterprises specializing in the provision of medical device transportation and storage services.
The quality management system of such enterprises shall comply with the requirements of
the "Good Management Practice for Medical Device Operation" and the "Appendix".
for the operation quality management practices of enterprises specializing in the provision of medical device transportation and storage services.
The quality management system of such enterprises shall comply with the requirements of
the "Good Management Practice for Medical Device Operation" and the "Appendix".
The Appendix puts forward specific requirements
for enterprises specializing in the transportation and storage of medical devices from the aspects of establishment and improvement of quality management system, 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, the Internet, and the Internet of Things in the modern logistics industry to promote the implementation of unique identification of medical devices and promote the traceability
of medical devices throughout the process.
Encourage enterprises to develop intensively, integrated and digitally, adopt new technologies to develop modern logistics, and improve the ability
of medical device supply guarantee services.
for enterprises specializing in the transportation and storage of medical devices from the aspects of establishment and improvement of quality management system, 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, the Internet, and the Internet of Things in the modern logistics industry to promote the implementation of unique identification of medical devices and promote the traceability
of medical devices throughout the process.
Encourage enterprises to develop intensively, integrated and digitally, adopt new technologies to develop modern logistics, and improve the ability
of medical device supply guarantee services.
