New Electronic Formatting Requirements for Class III and Class IV MDL Applications

As part of Health Canada’s “ongoing efficiency measures and efforts to reduce regulatory burden on industry and transition to an electronic environment, … [Health Canada announced on November 10th 2014] that Class III and IV Medical Device Licence applications will now be accepted in electronic-only format if they meet the requirements of this notice, effective immediately.” Importantly, these new electronic requirements will be required for any subsequent documentation “submitted in support of the application,”  such as: “responses to Screening Deficiency Letters, Clarification Requests, and Additional Information Letters.” Class III and IV applications previously submitted in paper will still have their supporting documentation accepted in paper but are encouraged to adopt the electronic format.

Moreover, “effective December 1, 2014, paper-based applications must also be structured in one of the” following formats:

  • “Health Canada’s guidance on supporting evidence
  • Summary Technical Documentation (STED)
  • International Medical Devices Regulators Form (IMDRF’s) Table of Contents (ToC) documents – under the upcoming implementation pilot”

“Class II medical device license applications, faxback amendments, and Investigational Testing Authorization (ITA) applications do not fall within the scope of this” new guidance, but are expected to be addressed in a future separate notice.

Pages 3-5 of this guidance discuss further the specific electronic data format, structure, content and media accepted for electronic data submission outlined by Health Canada.

To view the guidance, please visit:
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/md-im/activit/announce-annonce/md_notice_im_avis_CIII_CIV_format_mise_en_forme-eng.pdf

Share Button