China NMPA Product Recall - Electronic colposcope

Hunan Hengxing Technology Co., Ltd. initiated a voluntary Class III recall in July 2020 for its Electronic Colposcope (Registration Code: 湘械注准20192180035, Model: WH-SMA, Batch: 20191219002). This action, reported by the National Medical Products Administration (NMPA) and Hunan Provincial Drug Administration, stemmed from the device's failure to meet its registered product technical requirements, signifying a significant quality control deficiency. The company's recall report was dated June 17, 2020. Under the NMPA's regulatory guidance, Hunan Hengxing Technology Co., Ltd. was mandated to undertake several corrective measures. These included forming a dedicated product recall team, ensuring the sales department effectively notified medical device distributors and users of the recall, and establishing a secure warehouse for storing recalled products in compliance with regulatory standards. Additionally, the company was required to promptly amend the product's registration to address the identified non-compliance. The recall specifically affected products distributed in the Wuhu region.