Mar 25, 2015

Canadian medical device market regulator Health Canada will start accepting electronic as well as hard copies of some Medical Device License (MDL) application forms starting April 1, 2015, and will also require separate fee forms to be submitted either electronically or via hard copy with application forms starting on that same date.

According to an email notice sent out March 18 by Health Canada, requiring separate application and fee forms for Class III and IV devices will help the regulator move closer to a fully electronic MDL application acceptance process. The shift to separate electronic application and fee form submissions will accompany a two-percent fee increase April 1st.

"Submissions that are paper-based, when in the established format, will continue to be accepted but applicants are encouraged to submit in electronic format," states a November 2014 Health Canada notice on electronic submissions. "Submissions that are already in progress after the effective date may switch to electronic-only responses."

Health Canada will continue to accept only hard copies of MDL applications for Class II devices as well as private-label and investigational testing applications until further notice, states the email. 

For more information on the MDL application process, please refer to our video overview of the Canadian medical device registration process.


  • Stewart Eisenhart