Smart Vision Labs has successfully registered the SVOne autorefractor in Canada as a Class II medical device. SVL received a Canadian Medical Device License through Health Canada.

SVL registered the SVOne autorefractor with the US FDA as a Class 1 Medical device in 2014, enabling the sale and distribution within the 50 states. Canada’s FDA equivalent is Health Canada. Health Canada ensures medical devices meet safety standards, and authorize companies to market and sell devices in the country. Last week Smart Vision Labs, in pursuing ISO certification, successfully registered the SVOne as a Class II medical device.

autorefractor in Canada

The Canadian registration extends our goal to make the SVOne autorefractor available in Canada and around the world. Marketing and selling medical devices is met with regulatory restrictions in every country. These regulations are designed to make sure manufacturers provide safe, effective and high-quality products.

This comes on the heels of our CE Mark announcement, enabling us to distribute our products in the European Union.