New Electronic Formatting Requirements in Canada for Class III and IV MDL Applications
Content provided by Emergo Group, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.
Health Canada, Canada’s medical device market regulator, has published new guidance requiring electronic formatting for most higher-risk Class III and IV Medical Device License (MDL) applications.
Set to take effect 1 December 2014, the new rules will require Class III and IV MDL applicants to submit premarket review documentation using one of three electronic formatting options:
- Health Canada’s guidance on supporting evidence,
- Summary Technical Documentation (STED)
- International Medical Device Regulators Forum’s Table of Contents.
The guidance includes instructions for folder structures and naming conventions to be used in electronic applications, as well as acceptable media to use in submitting applications.
The new electronic filing requirements guidance does not apply to Class II MDL applications, faxback amendments or Investigational Testing Authorizations. Health Canada plans to address filing requirements for these types of documents in a separate guidance.