Submits application for regulatory approval in China
After extensive testing in China and compilation of the required documentation, VibroSense 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.
“The submitted application to the NMPA is a big step towards regulatory approval in China. The application consists of a large number of signed documents, several of which have been authenticated by a notary public. VibroSense has now passed an important milestone on the way to establishing sales in China, via its distributor and partner UMCARE. Our goal is to start sales in China during Q2 2024," says Hans Wallin, CEO VibroSense Dynamics AB.
About diabetes in China
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 SEK 800 billion per year.
Contact
Hans Wallin, CEO 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 develops and sells medical technology products and services to facilitate diagnosis of 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.