SCA®, approved as Class 2 Medical Device in Canada – September 1st

Great news! Health Canada has come through with approval for the Sperm Class Analyzer® to be classed as Class 2 Medical Device.

The Health Canada’s Therapeutic Products Directorate ensures the safety, effectiveness and quality of medical devices in Canada by a combination of pre-market review, post-approval surveillance and quality systems in the manufacturing process. Health Canada’s requirements for class II, III and IV devices are higher than the standards employed in the US.

You can download a copy of the certificate here.

More information: Health Canada website