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
    • 2.3.4 Canada's access to medicines regime
  • 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:

  Updated: 2015/05/18 (see all updates)

  Consulted: yyyy/mm/dd (see all consultations)

  Part of topic(s): Guidance on legislation, (other relevant topic or content)

  For assistance

  Contact:

  Application and Invoice Inquiries
  Medical Device Bureau, Device Licensing Services Division
  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
  By fax: 613-941-0825