According to the requirements of the "Regulations for the Supervision and Administration of Medical Devices" and other relevant laws and regulations, in order to strengthen the quality management of the transportation and storage process of medical devices that require refrigeration and freezing, and to ensure that medical devices are always in compliance with the temperature requirements of the instructions and labels for medical devices in the production, operation, and use of various links, the FDA has drafted the "Guidelines for the Cold Chain Management of Medical Devices (Transportation and Storage).
In a nutshell, the cold chain management of medical device business enterprises is mainly for in vitro diagnostic reagents and the need for refrigeration, freezing medical devices.
Specifically, you can visit: