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 previous forecast which was December 2024.
The response from the NMPA ”Supplementary Notice” contains many questions. The overall assessment is that it is a positive response from NMPA and that the questions are connected to the fact that the VibroSense Meter II instrument represents a completely new technology that is not known in China.
UMCARE's work to answer NMPA's questions will take about 2 months longer than planned and their answer is now estimated to be ready in November 2024 compared to September as previously announced. The NMPA will then review the responses and return with a final statement. As a result of Christmas holidays and the Chinese New Year, it is estimated that an approval can be ready during April 2025.
“The Chinese regulatory authority NMPA is currently under heavy load as a result of numerous applications combined with updated regulatory requirements. For UMCARE, this means that they do not have the same opportunities to discuss various issues with the authority, which means that the regulatory application process takes longer time. It is often difficult to know in advance how long it will take to get a regulatory approval, but the process is now in its final stages. One positive thing, however, is that no questions or objections from the NMPA are considered serious, nor have there been any questions regarding clinical studies in China. We continue to work together with UMCARE to reach all the way to a regulatory approval and then begin our launch in China", says Toni Speidel, CTO VibroSense Dynamics AB.
About UMCARE and Diabetes in China
UMCARE is a subsidiary of China General Technology Group (Genertec). The company is China's 42nd largest state-owned company. In February 2022, VibroSense signed a distributor agreement with UMCARE that gives UMCARE an exclusive time-limited exclusive right to sell the VibroSense Meter II throughout China for three years. The distributor agreement also includes a binding order of EUR 3.8 million with fixed minimum calls during three years. UMCARE also holds VibroSense's application for regulatory approval in China. UMCARE plans to begin sales in China immediately once regulatory approval is in place.
According to a 2020 estimate by the American Diabetes Association (ADA), there are approximately 130 million patients with diabetes in China, making the country the largest market for diabetes care in the world. There are about 36,000 hospitals, of which 24,000 are private and 12,000 are public. The cost of diabetes care is estimated at the equivalent of 70 billion EUR per year.
Contact
Toni Speidel, CTO VibroSense Dynamics AB
Tel: +46 40 88 026
Email: info@vibrosense.com
www.vibrosense.se
"The new Gold Standard for reliable
detection of nerve damage"
About VibroSense Dynamics AB (publ)
VibroSense Dynamics AB (publ) develops and sells medical technology products to facilitate diagnosis of peripheral nerve damage in the hands and feet. The method involves measuring and quantifying the ability to perceive vibrations at several frequencies. The company's customers are diabetes clinics, occupational health care, hospitals, point of care centers and researchers.
Our vision is for the company's products to be a standard instrument in all neurological examinations to detect early signs of changes in sensation so that patients and their caregivers can implement preventive measures that prevent, reduce or delay the onset of nerve damage in the hands and feet.