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China’s Food and Drug Administration (CFDA) has issued the country’s first Good Supply Practices (GSP) regulations that apply to all Class 1, 2 and 3 medical device distributors, as well as third-party logistics service providers for medical devices.

The GSP regulations establish minimum standards for device procurement, delivery acceptance, storage, sales, transportation and after-sales services. Distributors must implement quality management systems that cover all aspects of the distribution process, such as the quality and training of personnel, cold storage and cold-chain transportation, as well as computer information and recordkeeping.

(CFDA GSP Regulations)