China NMPA Product Recall - Silicone nasal implants and facial implants

On November 9, 2020, the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration announced a voluntary Class III recall concerning silicone nasal and facial implants. The recall was initiated by Hans Biomed Corp., the product manufacturer, and facilitated by its agent, Shanghai Hongman Trading Co., Ltd. The primary issue prompting this action involved significant omissions or inaccuracies found on the product's outer packaging labels and within the instruction manuals. These labeling discrepancies pertained to products registered under NMPA registration number 国械注进20193131979. Importantly, the recall specifically targets certain models, specifications, and batches, as detailed in an accompanying Medical Device Recall Event Report Form, and does not impact products already in use by patients. This proactive measure underscores the commitment to regulatory compliance and patient safety, ensuring that medical devices distributed meet stringent information disclosure requirements. The voluntary recall demonstrates adherence to established medical device regulations overseen by the NMPA, aiming to rectify informational deficiencies and maintain consumer trust in product specifications.