VibroSense Dynamics AB (publ) has submitted an application for regulatory approval for the Company's product VibroSense Meter®? II, to the Chinese authority National Medical Products Administration (NMPA). In February 2022, VibroSense signed an exclusive distributor agreement with the state-owned Chinese company Genertec Universal Medical Group (UMCARE).

The agreement includes a commitment that UMCARE will assist VibroSense with the application for regulatory approval at NMPA. An approval required for UMCARE to sell the VibroSense meter®? II product with the application Diabetic Foot Screening in China.

The agreement with UMCARE also includes a binding order of 3.8 MEUR that extends over three years, with fixed annual minimum calls, from the time of regulatory approval from NMPA. After a very extensive work, UMCARE has had the product VibroSense Meter?? II tested by a Chinese testing institute which has approved the product as a "medical device class II" in China.

In the last step towards an approval, UMARE has now submitted a complete application to NMPA for review of all documentation with associated test protocols. NMPA is expected to report back within 2-3 months from today's date. The notice from the NMPA can either be a regulatory approval or a request for additional information.