Shanghai Issues Report on Special Inspection of Third-Party Medical Device Logistics Companies

China Quality News Network reported that on January 14, 2020, the Shanghai Municipal Drug Supervision and Administration Bureau released an announcement on its official website stating that in order to strengthen the supervision of third-party logistics companies for medical devices in the city, implement the main responsibilities of enterprises, and urge enterprises to conduct medical device storage and distribution services legally and compliantly, the bureau organized a special inspection of some third-party medical device logistics companies in the fourth quarter.

I. Inspection Arrangements and Focus

This special inspection was conducted on 20 third-party logistics companies holding Shanghai's "Medical Device Business License" and whose license scope of business is "providing storage and distribution services for other medical device production and operation enterprises".

In accordance with relevant regulations such as the "Quality Management Specifications for Medical Device Operation", "Management Guidelines for Medical Device Cold Chain (Transportation, Storage)", and "Implementation Rules for Quality Management Specifications for Medical Device Operation in Shanghai", the inspection focused on whether the actual storage and transportation situation of third-party logistics companies is consistent with the licensed items, whether products are stored and transported in accordance with the requirements of medical device product labels and markings, whether the network real-time monitoring information platform provided to the regulatory authorities is consistent with the actual situation, whether the company's 2018 self-inspection report is true and valid, and whether the problems found in the previous year have been rectified and implemented.

II. Problems Found and Handling Measures

1. Shanghai Luocheng Medical Devices Co., Ltd. used its licensed medical device warehouse for other purposes. The warehouse stored hazardous chemicals and failed to store them according to label markings. It did not conduct audits of the qualifications of some first-time suppliers and first-time storage and transportation conditions, and its quality management system had serious defects. Please further investigate the suspected illegal and irregular activities of the enterprise by the market supervision bureau where the enterprise is located and handle it according to law and regulations.

2. FedEx Express (China) Co., Ltd. Shanghai Branch sublet its licensed medical device warehouse to other companies, and there were illegal acts such as failing to implement the business quality management system as required. Please further investigate the suspected illegal and irregular activities of the enterprise by the market supervision bureau where the enterprise is located and handle it according to law and regulations.

3. The licensed items of Shanghai Zhixin Medical Supply Chain Management Co., Ltd. were inconsistent with the actual situation, and the company was ordered to rectify within a time limit.

4. Shanghai Kangmei Pharmaceutical Co., Ltd. and Kerry Logistics Shanghai Branch voluntarily submitted applications to suspend operations.

The bureau has requested relevant regulatory departments to urge relevant enterprises to implement rectification measures based on the above handling measures, severely crack down on illegal and irregular activities in accordance with the law, and promptly eliminate risks and hidden dangers.