China NMPA Inspection - Xi"an Chenfang Sicheng Technology Co., Ltd. - April 19, 2023

The National Medical Products Administration (NMPA) conducted a surprise inspection of Xi'an Chenfang Sicheng Technology Co., Ltd., recently culminating in an announcement on April 19, 2023. The inspection uncovered serious deficiencies across the company's quality management system, non-compliant with the Good Manufacturing Practice for Medical Devices (GMP) and its relevant appendices. Key violations included organizational and personnel shortcomings, where the management representative failed to adequately improve the quality management system, and an inspector demonstrated insufficient knowledge regarding crucial product testing. In design and development, the company initiated product changes, such as screen and data cable alterations, without fully identifying or verifying potential product quality risks. Furthermore, significant lapses were found in software configuration management, with an absence of required tools and documentation for updates and defect management. Production management issues were also identified, specifically a discrepancy between the displayed software version of a "Dynamic Blood Pressure Recording and Analysis System" and its official technical requirements. As a result, the Shaanxi Provincial Drug Administration has been mandated to suspend the company's production. Xi'an Chenfang Sicheng Technology Co., Ltd. must assess the safety risks of its products and recall any potentially hazardous items. Production will only be allowed to resume following complete rectification of all deficiencies and a successful re-inspection by the Shaanxi Provincial Drug Administration, with further legal actions to be taken for regulatory violations.