NMPA Suspends Import And Use Of Swedish XVIVO Perfusion System Due To Major Findings From Remote Overseas Inspection

Recently, the NMPA has announced the suspension of import, distribution, and use of the Swedish XVIVO Perfusion System, approved for use since August 16, 2023, due to major findings from remote overseas inspection.

The NMPA had organized a remote inspection of XVIVO Perfusion AB, to inspect the XVIVO Perfusion System. During the inspection, inconsistency was found, particularly concerning the product’s manufacturing location and the information provided in the registration certificate.

In accordance with the relevant provisions of the Regulations for the Supervision and Administration of Medical Devices and to ensure the safety of medical equipment for the public, the NMPA has made the decision to suspend the import, distribution, and use of the XVIVO Perfusion System from XVIVO Perfusion AB with immediate effect.

This move underscores the NMPA’s commitment to upholding the safety and regulatory standards of medical devices available in the Chinese market, with a focus on consistency and accuracy in product information.

For more information and any questions on your post-market compliances in China, please contact info@bradyknowsmedical.com.