Service Standard for Medical Device Establishment Licences under the Medical Devices Regulations

Service Description:

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

The Medical Devices Regulations have been established under the authority of the Food and Drugs Act and outline the responsibilities of persons who import or sell medical devices in Canada, as well as Health Canada's responsibilities. It describes what a medical device establishment licence (MDEL) is, when it is required, and the activities covered under an MDEL.

The Guidance on Medical Device Establishment Licensing (GUI-0016), is intended to explain sections 44 to 51 of the Medical Devices Regulations (hereinafter referred to as the Regulations) which refer to medical device establishment licensing.

In the guidance, the application process is described, including how to obtain a new licence, how and when to amend an existing licence and the annual licence review.

Service Standard:

The Regulatory Operations and Enforcement Branch (ROEB) of Health Canada commits to a service delivery standard of 120 calendar days for the issuance of a decision regarding a complete application for an MDEL, including annual licence review applications, from the day it is received and acknowledged by Health Canada.

Performance Target:

The target for achieving these standards within a fiscal year is set at 100% of MDEL applications being completed within the than 120 days.

Performance Results 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 Departmental Results Report, which is normally tabled in Parliament and published in the third quarter (October-December) of the following fiscal year.

In 2020-2021, the performance target to issue decisions on MDEL applications was met 80% of the time by ROEB's Medical Device Compliance Program and it took 62 days on average to issues decisions.

To note, there was a significant increase of approximately 85% of MDEL holders over previous year, in response to the demand for COVID-associated devices (such as gowns, gloves, respirators, etc.) during the pandemic.

Departmental Contacts:

Please contact the Medical Devices Compliance and Licensing Unit to make any general inquiries or comments:

Medical Devices Establishment Licence Unit (MDELU)

200 Eglantine Driveway
3^rd Floor, Jeanne Mance Building
Address Locator: 1903C
Ottawa, Ontario K1A 0K9
E-mail: mdel.questions.leim@hc-sc.gc.ca