The industry standard for the "In vitro diagnostic reagent temperature control logistics service spe



On July 13, 2018, the General Office of the National Development and Reform Commission issued the '2018 Recommended Logistics Industry Standard Project Plan' (second batch) (Development and Reform Office Economic and Trade [2018] No. 813). Listed in the 2018 industry standard plan, a total of 11 items, involving e-commerce logistics, pharmaceutical logistics, automotive logistics, emergency logistics, bulk goods, shelves and other logistics management, basic, method standards.


The “In vitro Diagnostic Reagent Temperature Control Logistics Service Specification” standard organized and drafted by Zhongwulian Pharmaceutical Logistics Branch was approved by the project and included in the 2018 logistics industry standard project plan.


China's GSP, 'Medical Device Management Quality Management Regulations', 'Medical Device Cold Chain (Transport, Storage) Management Guide' and other regulations on the overall temperature control of the storage and transportation of medical devices, for in vitro diagnostics There are no clear and detailed regulations for medical devices with special properties such as reagents. This line of regulation specifies the requirements for receipt, acceptance, storage, in-house inspection, delivery, transportation, temperature monitoring and control, facility equipment, personnel and training, and after-sales service in the in vitro diagnostic reagent logistics process. It is suitable for the logistics process in which the temperature of the in vitro diagnostic reagent is controlled within the specified range during the production, operation and use by using special facilities and equipment.


Next, the standard will enter the startup phase.