NeuroMetrix has reported the receipt of marketing certification from Technischer Uberwachungs-Verein SUD Japan (TUV SUD Japan) for NC-stat DPNCheck as a Class II Designated Controlled Medical Device as defined in the technical standards of the Japan Ministry of Health, Labor, and Welfare.
NC-stat DPNCheck is a rapid, accurate and quantitative point-of-care test to detect diabetic peripheral neuropathy, or DPN, at an early stage allowing physicians to select appropriate treatment.
The regulatory process was managed by Omron Healthcare. As the company’s exclusive distributor for Japan, Omron initiated a DPNCheck product awareness campaign at the recent annual meeting of the Japan Diabetes Society. TUV SUD Japan approval will allow Omron to shift from market education to direct sales promotion.
NeuroMetrix president and CEO Shai Gozani said that Omron skillfully guided DPNCheck through the Japan regulatory process.
"TÜV SÜD Japan approval allows us to finalize product labeling and, within the next few weeks, initiate DPNCheck shipments to Japan. Working closely with Omron over the past year has also helped us develop a solid partnership foundation which should serve us well in this and other large Asian markets," Gozani added.