Regulatory application in China receives "Notice of Acceptance" status
VibroSense Chinese distributor UMCARE, announces that it has received a so-called "Notice of Acceptance" from the Chinese authority NMPA, regarding the company's application for regulatory approval in China for VibroSense Meter ® II and Diabetic Foot Screening.
In a next step, a "Supplementary Notice" is expected to be received from the NMPA during June 2024. Thereafter, the application enters the final stage which includes final supplements before a certificate can be issued by the NMPA, which is expected to be ready in December 2024. The new timetable, which was communicated on March 12, 2024, applies on the condition that the NMPA does not require clinical studies in China, which UMCARE has assessed as less likely.
Obtaining "Notice of Acceptance" status is an important step in the regulatory application process, after which a final review of all documents begins. This review is expected to be completed in June 2024, at which NMPA will issue a "Supplementary Notice". During September 2024, it is estimated that all items in the "Supplementary Notice" will be adjusted. Next, NMPA completes the final step of regulatory approval, where a certificate is issued that gives VibroSense the right to sell the VibroSense Meter® II in China, which is expected to be completed in December 2024.
"We are now finally getting closer to regulatory approval in China as our application has received a "Notice Of Acceptance" status. This is an important milestone for VibroSense! Once the regulatory certificate is issued by NMPA, we are ready to start deliveries to China immediately, followed by sales activities in the Chinese market. This will then give a direct positive impact on the company's sales, which we have been waiting for a long time," says Hans Wallin, CEO of 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 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 calls for 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 USD 80 billion per year.
Contact
Hans Wallin, CEO VibroSense Dynamics AB
Tel: +46 40 88 026
Email: [email protected]
www.vibrosense.com
"The new Gold Standard for reliable
detection of nerve damage"
About VibroSense Dynamics AB ( pub )
VibroSense Dynamics AB (publ) develops and sells medical technology products and services for diagnostic support for nerve damage in the hands and feet. The method involves measuring and quantifying the ability to feel vibrations at several frequencies. The company's customers are diabetes clinics, occupational health care, hospitals, health centers and researchers.
Our vision is that the company's products should 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.