Because the license business scope for the "other medical equipment production and management enterprises to provide storage, distribution services" special inspection failed, Shanghai Kangmei Pharmaceutical Co.
In order to strengthen the city's medical device third-party logistics enterprise supervision, the implementation of the main responsibility of enterprises, urging enterprises to legally comply with the medical device storage, distribution services, the Shanghai Municipal Drug Administration in the fourth quarter of the organization of the third-party logistics of medical devices part of the enterprise to carry out a special inspection. According to the "Medical Device Business Quality Management Standard" "Medical Device Cold Chain (Transportation, Storage) Management Guide" "Shanghai Medical Device Business Quality Management Standard Implementation Rules" and other relevant provisions, focusing on the third-party logistics enterprises, the actual storage and transportation of whether the licensing matters, whether in accordance with the requirements of the labeling of medical equipment products, labeling of the product storage, transportation, provided to the regulatory authorities of the network Real-time regulatory information platform is consistent with the actual, whether the enterprise 2018 annual self-inspection report is true and effective, whether the problems found in the previous year are rectified and implemented, etc. to carry out verification.