China NMPA Product Recall - box-type hearing aids

The National Medical Products Administration (NMPA) announced on December 3, 2019, a voluntary product recall initiated by Kunming Zhengkang Medical Device Co., Ltd. The recall pertains to the company's box-type hearing aids, identified under Registration No.: Dianxiezhuzhun 20162460080. This action followed a quality supervision inspection conducted by the Yunnan Provincial authorities. The primary issue discovered during the inspection was that the external markings of the equipment components did not conform to established standards. In response to this non-compliance, Kunming Zhengkang Medical Device Co., Ltd. has taken the required action to implement a Level III voluntary recall of the affected products. The regulatory framework for this recall falls under the purview of the NMPA, with the incident reported via the Yunnan Provincial Drug Administration Website. Further specifics regarding the models, specifications, and batch numbers of the recalled hearing aids are detailed in an accompanying Medical Device Recall Event Report Form.