Management of Applications for Medical Device Licences - Summary

From Health Canada

Overview

This guidance document provides information to industry and health care professionals on how Health Canada manages applications for medical device licences.

Who this guide is for

All Medical Device Licence holders or potential Medical Device Licence holders

In this guide

• 1. Introduction
  • 1.1 Purpose/Overview
  • 1.2 Scope
  • 1.3 Policy Objective
  • 1.4 Policy Statements
• 2. Guidance for Implementation
  • 2.1 Filing of Medical Device Licence Applications
  • 2.2 Guidance Documents, Policies, and Application Forms
  • 2.3 Target Performance Standards in Calendar Days
  • 2.4 Administrative Screening
    • 2.4.1 Acceptable Applications
    • 2.4.2 Incomplete Applications
  • 2.5 Regulatory Screening
    • 2.5.1 Acceptable Original Information
      • 2.5.1.1 New Class II Licence Applications, Class II Licence Amendments, New Private Label Licence Applications, and Private Label Licence Amendments
      • 2.5.1.2 New Class III and Class IV Licence Applications and Class III and IV Licence Amendments (for Significant Changes)
      • 2.5.1.3 Licence Amendment Minor Changes (Faxbacks)
    • 2.5.2 Incomplete Original Information
      • 2.5.2.1 New Class II Licence Applications, Class II Licence Amendments, New Private Label Licence Applications, and Private Label Licence Amendments
      • 2.5.2.2 New Class III and Class IV Licence Applications and Class III and IV Licence Amendments (for Significant Changes)
      • 2.5.2.3 Licence Amendment Minor Changes (Faxbacks)
  • 2.6 Technical Screening
    • 2.6.1 Acceptable Original Information
    • 2.6.2 Incomplete Original Information
      • 2.6.2.1 Screening Deficiency Notices
      • 2.6.2.2 Rejection Letters
  • 2.7 Administrative Processing
  • 2.8 Review
    • 2.8.1 Clarification Requests
    • 2.8.2 Requests for Additional Information
    • 2.8.3 Refusal Letters
    • 2.8.4 Withdrawal Letters
  • 2.9 Reviewers' Report
  • 2.10 Unsolicited Information
  • 2.11 Re-Filed Applications
    • 2.11.1 Re-Filing Within Six (6) Months
    • 2.11.2 Re-Filing After Six (6) Months
    • 2.11.3 Re-Filing of a Rejected Application
  • 2.12 Fees
  • 2.13 Pause the Clock
  • 2.14 Opportunity to be Heard Process
    • 2.14.1 Reconsideration: Bureau Director
    • 2.14.2 Appeal: Director or Delegate and Appeal Committee
    • 2.14.3 Impact on Review Process

View complete guide

Download PDF (287 KB, 22 pages)

Details and history

Published: 2001-03-27
Date Posted: 2019/11/08
Effective Date: 2020/04/01
Part of topic(s): Guidance on legislation

For assistance

Contact Us:

Application and Invoice Inquiries
Medical Device Directorate, Device Licensing Services Division
Health Canada
11 Holland Avenue
Address Locator 3002A
Ottawa, Ontario K1A 0K9
By email: meddevices-instrumentsmed@hc-sc.gc.ca
By phone: 613-941-7285

Invoice Payment Inquiries
Accounts Receivable
Address Locator: 1918B
18^th Floor, Room 1804B, Jeanne-Mance Building
161 Goldenrod Driveway, Tunney's Pasture
Ottawa, ON K1A 0K9
By email: hc.ar-cr.sc@canada.ca
By phone: 613-957-1052 or 1-800-815-0506
By fax: 613-957-3495