Medical Device Quality Alert: NMPA Inspection Results
2023-11-21
The National Medical Products Administration (NMPA) has released findings from its recent quality inspection, revealing that 20 batches of medical devices across 11 categories have failed to meet the necessary compliance standards.
Key findings include non-compliance in products like anesthesia breathing circuits, soft contact lenses, various therapeutic patches, sterile surgical drapes, radiation protection gear, Nd:YAG laser therapy machines, electric gastric lavage machines, infusion pumps, ECG machines, medical oxygen concentrators, and infant phototherapy units from multiple manufacturers.
The NMPA is taking action by instructing provincial drug authorities to enforce administrative measures, including mandatory product recalls and public announcements of such actions. Manufacturers are being directed to conduct risk assessments, determine recall levels based on the severity of defects, and initiate voluntary recalls while providing public recall information.
Additionally, manufacturers are required to identify the root causes of non-compliance, develop corrective strategies, and ensure timely rectification of the issues.
The NMPA remains dedicated to safeguarding public health by enforcing strict quality standards for medical devices and will continue to provide updates on these matters.
Stay informed with the latest healthcare updates from BradyKnows Medical (www.bradyknowsmedical.com). At BradyKnows Medical, we stand by the commitment to quality and patient safety. We’ll continue to monitor and inform you of developments in medical device standards and regulations.
