NMPA suspends the import, operation and use of the Samo Trekking knee system & Components of hip prosthesis

NMPA organized a remote off-site inspection of SAMO S.p.A (Italy) for Trekking knee system and Components of hip prosthesis. The inspection found that Samo company in Italy did not effectively identify Chinese regulatory requirements, product technical requirements and size parameters identification errors, etc. The comprehensive evaluation concluded that it did not meet the requirements of China’s Good Manufacturing Practice for Medical Devices and Good Manufacturing Practice Appendix for Implantable Medical Devices.