Medical device third-party logistics enterprises shall establish a management organization suitable for their business scale and business scope, and be equipped with specialized logistics management, operation and maintenance personnel. For medical device third-party logistics enterprises that carry out refrigeration and freezing business such as in vitro diagnostic reagents, due to the particularity of reagents, the whole chain cold chain operation process is relatively complex and has a certain degree of professionalism, so the qualification ability and practical skills of medical device third-party logistics personnel are required to be higher.
In the management and system construction of third-party logistics related personnel of medical devices, it is necessary to pay attention to:
1. The construction of the organizational structure and the rationality of the system of the third-party logistics enterprise of medical devices. Medical device third-party logistics enterprises should clarify the needs or quantities of personnel in each operation process, clarify job responsibilities, and achieve a clear division of labor and clear authority. Medical device third-party logistics enterprises should establish a personnel training and assessment system and clarify the retraining requirements. Third-party logistics enterprises of medical devices should formulate operating procedures and management systems for each storage and transportation link, and the relevant documents should be operable.
2. The cultivation of the ability of third-party logistics personnel for medical devices. The management, operation, and maintenance personnel of medical device third-party logistics enterprises should have professional knowledge of refrigeration and freezing, and should be familiar with laws, regulations and standards such as medical devices and cold chain. Personnel in key logistics operation positions such as warehousing acceptance, delivery, and review of third-party logistics of medical devices should undergo theoretical training and operation practice, and be familiar with standard operating procedures.
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