NMPA Inspection: Importation Halted Due to Address Discrepancies

The NMPA issued an inspection result on October 25, 2023, for the inconsistence of manufacturing addresses.

NMPA organized a remote inspection of XVIVO Perfusion AB, a Swedish medical technology company. The inspection focused on their lung perfusion system (XVIVO Perfusion System), a Class III device. It was approved in August 2023.

During the inspection, discrepancies were found between the product’s actual production address and the information on the registration certificate. As a result, the NMPA has decided to suspend the import, distribution, and use of the XVIVO Perfusion System from XVIVO Perfusion AB 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