May 12, 2015

Health Canada has released new information regarding common issues its reviewers found over the course of 2014 and early 2015 with higher-risk Medical Device License (MDL) applications that result in additional information requests to applicants.

In a Health Canada performance report provided by Canadian trade association MEDEC, the most common requests for additional information for Class III and IV new and amended MDL applications include:

  • Information on safety and effectiveness studies
  • Documentation on device and package labeling
  • Background information
  • Marketing history and regulatory status

In addition, Health Canada cited the following issues as most common screening deficiencies agency reviewers see in Class III and IV new and amendment MDL applications:

  • Safety and effectiveness studies
  • Background information
  • Associated fees
  • Device and package labeling documentation
  • Manufacturing quality controls
  • Licensing
  • Marketing history and regulatory status (for non-IVD applications)

However, Health Canada continues to complete most MDL applications with no additional information requests: The regulator approved 59% of MDL applications without such requests during the first quarter of 2015, up from 57% of applications in the last quarter of 2014.

Furthermore, Health Canada reviewers have consistently found about 80% of all MDL application submissions to be at least adequate between July 2014 and February 2015. This suggests that a large majority of applicants have a clear understanding of what their MDL submissions should include and address. Still, future MDL applicants should note these Health Canada findings to minimize the risk that they’ll receive additional information requests, or that their Canada registration efforts will be delayed or complicated due to deficiencies.


  • Stewart Eisenhart