The NMPA issued an inspection result on July 19, 2023, identifying the size error in product technical requirement (PTR).
NMPA organized a remote inspection of SAMO S.p.A, an Italian orthopedic company. The inspection focused on their artificial knee joint system and cementless artificial hip joint system, the Class III devices.
It was found during the inspection that SAMO had issues such as failing to effectively identify Chinese regulatory requirements and errors in the dimensional parameter identification in PTR. As a result, the NMPA has decided to suspend the import, distribution, and use of the two devices with immediate effect, based on the Decree 739 Regulation on Supervision and Management of Medical Devices.
In September 2023, a Korean manufacturer Prestige Medicare’s pelvic organ prolapse repair system was found with defects in remote inspection. The actual production process of this product is inconsistent with that of production process flow chart, and testing is not carried out in accordance with the registered PTR (product technical requirement). The penalty was also the suspension of the import, distribution, and use.
For other inspection results, please click HERE
China Med Device Cited by RAPS on NMPA Overseas Inspection. Click HERE for the article
Click HERE for the list of devices mentioned in the 2023 National Inspection Plan