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 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 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 and when it is required, who is required to hold a licence, and the activities covered under an MDEL.

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

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

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 an application for an MDEL, including annual review applications, from the receipt date of a complete application.

Performance Target:

The target for achieving these standards within a fiscal year is set at the average time to complete MDEL applications being no greater than 120 days.

Performance Results in fiscal year 2017 to 2018:

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 2017-2018, the performance target to issue decisions on MDEL applications was met 100% of the time by ROEB's Medical Device Compliance Program.

Departmental Contacts:

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

Medical Devices Compliance and Licensing Unit (MDCLU)
251 Sir Frederick Banting Driveway
3rd Floor, Sir Frederick G. Banting Research Centre
Address Locator: 2203B
Ottawa, Ontario K1A 0K9

E-mail: hc.mdel.questions.leim.sc@canada.ca