Service Standard for Right to Sell a Licensed Medical Device under the Medical Devices Regulations – Health Canada

Service Description:

Health Canada posts service standards and performance information for services with over 100 regulatory authorizations, such as permits or licences, issued each year (high-volume regulatory transactions).

The Medical Devices Regulations have been established under the authority of the Food and Drugs Act and apply to all medical devices imported or sold in Canada. The Medical Devices Regulations set out the requirements governing the sale, importation, and advertisement of medical devices in Canada.

The Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices guidance document provides medical device manufacturers and their regulatory correspondents with the steps involved in renewing a medical device licence. The renewal process has two purposes. The first is to confirm whether the medical device will continue to be sold in Canada and the medical device licence will remain active; the second is to collect information that must be assessed prior to invoicing for the right to sell fee.

Service Standard:

Health Products and Food Branch (HPFB) commits to service delivery standard of 20 calendar days, from deadline for receipt of annual notification, to update the Medical Devices Active License Listing database.

Performance Target:

The target for achieving this standard is set at 90% of updates made within the applicable review timelines.

Performance result in fiscal year 2020 to 2021:

Annual service performance is measured over the course of the fiscal year (April 1 - March 31). Performance results for a given fiscal year are published in the Report on Fees, which is normally tabled in Parliament and published in the third quarter (October-December) of the following fiscal year.

The HPFB processed 99.96% of the updates within the service standard.

Departmental Contacts:

To make any general inquiries or comments, please contact:

Bureau of Licensing Services
Medical Devices Directorate
Health Canada
11 Holland Avenue, Tower A 2^nd Floor
Address Locator: 3002A
Ottawa, Ontario
K1A 0K9
Phone: 613-957-7285
E-mail:  meddevices-instrumentsmed@hc-sc.gc.ca

On Cost Recovery:
E-mail:  cro-brc@hc-sc.gc.ca
Telephone: 613-617-7323
Fax: 613-954-9981