Health Canada to Stop Accepting Hard Copies of Class III, IV MDL Application and Fee Forms
Content provided by Emergo, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.
Canadian medical device market regulator Health Canada will stop accepting hard copies of some Medical Device License (MDL) application forms starting 1 April 2015, and will also require a separate fee form to be electronically submitted with application forms starting on that same date.
According to an email notice sent out 18 March 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 as of 1 April 2015.
Health Canada will continue to accept 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.