China NMPA Inspection - Sichuan Hengming Technology Development Co., Ltd. - August 01, 2018

During an unannounced inspection conducted from July 11-12, 2018, Sichuan Hengming Technology Development Co., Ltd., a manufacturer of Specific Electromagnetic Spectrum Therapy Devices, was found to have multiple deficiencies related to its quality management system. The inspection, based on "Good Manufacturing Practice for Medical Devices," revealed several key issues. The company failed to timely record the usage of electrical safety testing instruments and exhibited inadequate document control, with operational instructions lacking proper identification and approval. Furthermore, significant problems were noted in product identification and traceability, as devices undergoing factory inspection lacked serial numbers, preventing a clear link to their inspection records. The design change management process was also cited, with design changes verified using only two typical models without assessing their coverage for all product variations. Finally, a device was found improperly stored in an ingredient preparation area without appropriate status markings. In response, the Sichuan Provincial Food and Drug Administration was directed to mandate rectification within a specified timeframe, conduct follow-up inspections, and require a comprehensive assessment of product safety risks. Any products deemed to pose safety hazards must be recalled in accordance with relevant regulations. The provincial administration is also required to report the rectification progress to the National Medical Products Administration.