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SFDA issues requirements for medical device distributors setting up warehouses out of the province where they are located



The State Food and Drug Administration (SFDA) issued requirements for medical device distributors setting up warehouses out of the province where they are located in order to strengthen the licensing of medical device distribution.

The Requirements prescribe that warehouses set up out of the province where the medical device distributors located must satisfy the local acceptance criteria and must be equipped with computer systems that exchange information on storage of medical devices and data of incoming and outgoing medical devices with the distributor's headquarters. To set up warehouses out of the province where they are located, medical device distributors should submit application and relevant documents to the authorities issuing their Medical Device Distributing Enterprise License. After verification and approval, the distributors should manage the warehouses set up and take up corresponding legal responsibilities in accordance with Regulations for Supervision and Administration of Medical Devices.

The Requirements stress that the activities of the warehouses set up out of the province where the medical device distributors located are confined to the distributors' purchases and sales and local food and drug regulatory departments are responsible for routine supervision to the warehouses.