Port communicationAaron Peng Yi talks about the conditions and procedures for applying for a medical device business license in 2025:The validity period of the medical device business license is 5 years。License number indicated、Company name、legal representative、Business person in charge、address、Business premises、Business style、Business scope、Warehouse address、Issuing department、Issue date and validity period, etc.。
Engaged in medical device business，The following conditions should be met： (one)Have quality management organizations or quality management personnel that are commensurate with the business scope and scale of operations，Quality management personnel should have relevant professional academic qualifications or professional titles recognized by the state; (two)Have operations that are commensurate with the business scope and scale of the business、storage place; (three)Have storage conditions suitable for the business scope and scale，If all storage is entrusted to other medical device operating enterprises, there is no need to set up a warehouse.; (Four)Have a quality management system suitable for the medical devices it operates; (five)Have professional guidance appropriate to the medical devices being operated、Technical training and after-sales service capabilities，Or agree to provide technical support from relevant institutions。
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