China NMPA Product Recall - Cerebral hemodynamic monitoring device

On November 23, 2021, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Shanghai Shicai Biotechnology Co., Ltd. This action pertains to their cerebral vascular hemodynamics monitor, identified by Registration Certificate No. 沪械注准20192070399.

The primary issues prompting this recall include concerns regarding the product's performance and composition. More critically, the company failed to promptly update the Medical Device Production Product Registration Form on its Medical Device Production License following the product's renewal registration. This oversight signifies a lapse in regulatory compliance, as accurate and up-to-date documentation is essential for medical device manufacturing and registration under the NMPA's regulatory framework.

As a required action, Shanghai Shicai Biotechnology Co., Ltd. is voluntarily recalling affected units of the cerebral vascular hemodynamics monitor. Further details regarding specific product models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form." This action underscores the importance of stringent adherence to regulatory documentation requirements to ensure product safety and compliance within the medical device industry.