China Takes Steps To Ensure Quality of COVID-19 Related Exports

Effective April 1, 2020, exporters of COVID-19 related medical devices (e.g. coronavirus testing reagents, medical masks, clinical thermometers, ventilators, etc.) will be required to present proof at Customs that the devices are notified or approved for use in China by the National Medical Products Administration (NMPA). The export clearance process will require the device’s Medical Device Registration Certificate (MDRC) and a declaration letter that the devices meet the quality standards of the importing nation or region from the exporting enterprise.

These measures are meant to prevent fraudulent or low quality devices from entering the world supply at a time when demand is so high and regulatory review in many countries is being expedited or waived for critically needed medical devices.

Interested international purchasers of such products are advised to request copies of the MDRC as one part of their vendor qualification process. Registration numbers from the certificates can be cross referenced against the NMPA’s on-line database of registered medical devices to confirm authenticity.  (Note: Both the MDRC and website are in Chinese language.)