China NMPA Inspection - Shanghai Shecheng Medical Devices Co., Ltd. - December 05, 2023

The National Medical Products Administration (NMPA) conducted unannounced inspections, revealing significant deficiencies in the quality management systems of Shanghai Shecheng Medical Device Co., Ltd. and Chengdu Xinxing Endoscopy Technology Co., Ltd.

Shanghai Shecheng Medical Device Co., Ltd. faced issues including inadequate personnel training and competency, untraceable material procurement and production records, improper identification of R&D prototypes, and critical failures in quality control. For example, a single individual performed multiple key quality roles, and product release occurred prematurely before complete inspection approval. This company has voluntarily cancelled its production license.

Chengdu Xinxing Endoscopy Technology Co., Ltd. also exhibited serious quality management failures. Violations included inconsistencies in procurement specifications, a lack of raw material traceability, and manufacturing a product (a flushing and suction instrument) with a structure inconsistent with its medical device registration certificate. Furthermore, finished product inspections were inadequate, lacking complete test records for critical parameters such as flow rates and pressure.

Both companies' systems were deemed non-compliant with the Good Manufacturing Practice for Medical Devices. Provincial drug regulatory authorities are required to enforce control measures, including production suspension, assess product safety risks, and initiate recalls if hazards are found. Production can only resume after full rectification and successful re-inspection.