Regulatory approval in China is delayed 4 months
The last and final step in obtaining regulatory approval of the VibroSense Meter ® II in China is delayed approximately four months. The delay is due to that VibroSense's Chinese distributor UMCARE has received many questions on its application, from the Chinese regulatory authority NMPA. According to UMCARE, the NMPA requires an extra careful review because there is no similar instrument in China, which is considered to be an advantage when the product is ready for launch in China. The regulatory approval is now estimated by UMCARE to be obtained at the end of April 2025 compared to their