Guidance Document - Medical device licence renewal and fees for the right to sell licensed medical devices

From Health Canada

Overview

This guidance document provides information to industry and health care professionals on the regulatory requirements for fees for the right to sell medical devices.

Who this guide is for

All manufacturers submitting a medical device for licence renewal.

In this guide

• 1. Introduction
  • 1.1 Objective
  • 1.2 Policy statements
  • 1.3 Scope and application
• 2. Guidance
  • 2.1 Annual licence renewal procedure
    • 2.1.1 Annual renewal package
    • 2.1.2 Return of the renewal form
    • 2.1.3 Processing the renewal form and invoicing
    • 2.1.4 Failure to renew
  • 2.2 Invoicing and fee payment
  • 2.3 Mitigation measures
    • 2.3.1 Small business
    • 2.3.2 Publicly funded health care institutions
    • 2.3.3 Government organizations
  • 2.4 Missed performance standards
  • 2.5 Applicable fees
  • 2.6 General contact information
• Appendix A: Fee deferrals and remissions

View complete guide

Details and history

Published: 2019-11-04

For assistance

Contact:

Application and Invoice Inquiries
Medical Device Directorate, Bureau of Licensing Services
By email: meddevices-instrumentsmed@hc-sc.gc.ca

Invoice Payment Inquiries
Accounts Receivable
Address Locator: 1918B
18th 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