China NMPA Product Recall - Medical bone matrix induction

Shanghai Xiaobo Technology Development Co., Ltd. initiated a voluntary Class III recall of its Medical Inducing Bone Matrix product, as reported by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration on August 9, 2021. The recall stems from an administrative issue where the production license for the Medical Inducing Bone Matrix contained an expired product registration certificate number. Furthermore, the company had not secured a renewed product registration certificate number, despite the expiration. This situation led to the recall of products previously distributed under the registration certificate number 国械注准20153132396. The regulatory framework for this action involves both the NMPA and the Shanghai Municipal Drug Administration, ensuring compliance with national medical device regulations. The company's required action is a voluntary Class III recall, with comprehensive details regarding affected product models, specifications, and batch numbers available in an attached "Medical Device Recall Event Report Form." This measure addresses the documentation discrepancy to uphold regulatory standards for medical device distribution in China.