Guidance on managing applications for medical device licences: Filing applications

Resources

There are numerous resources available to help manufacturers prepare and file medical device licence (MDL) applications.

If you’re a manufacturer, or an authorized regulatory correspondent for the manufacturer, and wish to file an MDL application, you should consult the following forms, tools, policies and guidelines:

You may also contact Health Canada’s Medical Devices Directorate (MDD) at meddevices-instrumentsmed@hc-sc.gc.ca before filing an MDL application if you still have questions. MDD also offers pre-submission meetings. Learn about the Medical Device Meeting Program.

Fees

For information on MDL application fees, consult:

Guidance document: Fees for the review of medical device licence applications

How to send applications

New and amendment MDL applications, and all other application-related regulatory transactions (for example, solicited and unsolicited information), must be filed using the Regulatory Enrolment Process (REP) and submitted through the Common Electronic Submissions Gateway (CESG).

Learn about:

Target timelines and performance standards

The following table gives the target timelines and performance standards for each type of MDL application.

Table 1: Target timelines and performance standards (in calendar days) for MDL applications
Type of application	New and amendment Class II applications^{Footnote 1}	New and amendment (significant change) Class III applications	New and amendment (significant change) Class IV applications	Minor change applications	New and amendment private label applications
Administrative screening	4^{Footnote 2}	4^{Footnote 2}	4^{Footnote 2}	4^{Footnote 2}	4^{Footnote 2}
Screening period
Regulatory screening	12^{Footnote 2}	5^{Footnote 2}	5^{Footnote 2}	4^{Footnote 2}	12^{Footnote 2}
Technical screening	n/a	7^{Footnote 2}	7^{Footnote 2}	n/a	n/a
Administrative processing	3^{Footnote 2}	3^{Footnote 2}	3^{Footnote 2}	3^{Footnote 2}	3^{Footnote 2}
Target performance standard^{Footnote 3}	15^{Footnote 3}	n/a	n/a	n/a	15^{Footnote 3}
Review period
Review 1^{Footnote 4}	n/a	57^{Footnote 2}	72^{Footnote 2}	n/a	n/a
Administrative processing	n/a	3^{Footnote 2}	3^{Footnote 2}	n/a	n/a
Target performance standard^{Footnote 3}	n/a	60^{Footnote 3}	75^{Footnote 3}	n/a	n/a
Review 2^{Footnote 5}	n/a	42^{Footnote 2}	42^{Footnote 2}	n/a	n/a
Administrative processing	n/a	3^{Footnote 2}	3^{Footnote 2}	n/a	n/a
n/a: not applicable Footnote 1 In some cases, Health Canada may review a Class II application before making a decision. In such cases, the target performance standard may not be met. Return to footnote 1 referrer Footnote 2 Target timeline for the application type. Return to footnote 2 referrer Footnote 3 Target performance standard is the number of days from the date an application is accepted for regulatory screening (Class II or private label) or review (Class III or Class IV) to the date of first decision. Return to footnote 3 referrer Footnote 4 Period from the date an application is accepted for review (date of screening acceptance letter) to the date of first decision. Excludes 3 days for administrative processing and clock pauses. Return to footnote 4 referrer Footnote 5 Period from the date a response to an additional information letter is received to the date of subsequent decision. Excludes 3 days for administrative processing and clock pauses. Return to footnote 5 referrer

Market authorization time

Market authorization time is the average time between when an MDL application is received and an MDL is issued. This period covers the entire application management process, including any time during which additional information is requested, the manufacturer’s response time, and the subsequent evaluation of the submitted information.

You may be asked to provide more information through a screening deficiency letter or an additional information letter. If you can’t provide the requested information within the original timeframe, you can ask for an extension through the REP. Submit your extension request as early as possible. The request must include a reason and a new proposed timeline that doesn’t exceed the original duration. Each request is reviewed on a case-by-case basis. Approval is not guaranteed.

Any time granted through an approved extension counts toward the market authorization time and may extend it.

You can stay informed about our latest average market authorization times by visiting Medical devices - market authorization time.

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2025-11-21

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