China NMPA Inspection - Tianjin Cheyuan Medical Technology Co., Ltd. - December 29, 2020

The National Medical Products Administration (NMPA) issued an announcement on December 29, 2020, following an unannounced inspection of Tianjin Cheyuan Medical Technology Co., Ltd. conducted prior to December 25, 2020. The inspection uncovered serious deficiencies in the company's quality management system, indicating non-compliance with China's Good Manufacturing Practice for Medical Devices.

Key violations included the company's inability to provide process validation reports and testing records for critical production processes, which contravenes Article 46. Furthermore, specified inspection indicators were not reflected in finished product inspection reports for main units and disposable sensors, violating Article 58. A significant traceability issue was identified where disposable sensor test report dates predated material requisition, assembly, and packaging activities, a breach of Article 59.

Consequently, the NMPA has mandated that Tianjin Cheyuan Medical Technology Co., Ltd. immediately suspend production for comprehensive rectification. The company is also required to assess product safety risks and recall any potentially hazardous products in accordance with the Regulations on the Recall of Medical Devices. Production resumption is contingent upon the successful completion of all corrective actions and passing a re-inspection by the Tianjin Municipal Drug Administration.