Service Standard for Medical Device Establishment Licences under the Medical Devices Regulations
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 and Medical Device Establishment Licence Fees (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.
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 licence review applications, from the day it is received by Health Canada.
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 2018 to 2019:
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 2018-2019, the performance target to issue decisions on MDEL applications was met 100% of the time by ROEB's Medical Device Compliance Program.
Please contact the Medical Devices Compliance and Licensing Unit to make any general inquiries or comments:
Medical Devices Compliance and Licensing Unit (MDCLU)
3rd Floor, Jeanne Mance Building
200 Eglantine Building
Address Locator: 1903C
Ottawa, Ontario K1A 0K9
Teletypewriter: 1-800-267-1245 (Health Canada)
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