NMPA Suspends Import and Sale of SAMO S.p.A Knee and Hip Prosthesis Systems

The National Medical Products Administration (NMPA) has issued a notice to suspend the import, sale, and use of the Trekking knee system and components of hip prosthesis manufactured by Italy-based firm SAMO S.p.A. This decision comes after remote non-onsite inspections revealed several compliance issues. The company was found to have ineffectively identified Chinese regulatory requirements, and there were inaccuracies in the labeling of product technical requirements and dimensional parameters. These discrepancies were determined to be non-compliant with China’s ‘Medical Device Production Quality Management Specification’ and its ‘Appendix Implantable Medical Devices to the Medical Device Production Quality Management Specification’.- Flcube.com