China NMPA Product Recall - Infrared spectrum therapy device

Anhui LG Health Technology Co., Ltd. initiated a voluntary Class III recall of its infrared spectrum therapy device (Registration No.: 皖械注准20142260015), as announced by the National Medical Products Administration (NMPA) on January 10, 2019, following the company's report on January 8, 2019. The primary issue prompting this recall was the non-compliance of the product's instructions with the regulatory requirements outlined in Appendix 1 of Document No. [2018]14, issued by the Drug Administration Office. This document pertains to the '2018 National Medical Device Sampling Inspection (Central Government Subsidized Local Project) Product Inspection Plan for Electromagnetic Wave Therapy Instruments.' The regulatory framework governing this action is the National Medical Products Administration of China, specifically enforced by the Anhui Provincial Drug Administration. The non-compliance points to deficiencies in the informational materials provided with the medical device, failing to meet established national standards for product labeling and user instructions. As a result, Anhui LG Health Technology Co., Ltd. was required to implement a voluntary recall to address these instructional discrepancies, with specific details regarding affected product models, specifications, and batches documented in the accompanying Medical Device Recall Event Report Form. This action underscores the NMPA's commitment to ensuring medical device instructions are clear, compliant, and safeguard public health.