Draft guidance on managing applications for medical device licences: Filing applications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 and you 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) before filing an MDL application if you still have questions. For information on pre-submission meetings with MDD, consult:

Medical device meetings draft guidance document

Fees

For information on MDL application fees, consult:

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

Where to send applications

New and amendment MDL applications, and all application-related documents (for example, solicited and unsolicited information) should be sent by email to devicelicensing-homologationinstruments@hc-sc.gc.ca.

Applications and application-related documents over 20 megabytes should be put on electronic media and mailed to:

Bureau of Licensing Services
Medical Devices Directorate
Health Canada
11 Holland Ave, Tower A
Address Locator: 3002A
Ottawa ON K1A 0K9

For a list of acceptable media formats, consult:

Draft Health Canada IMDRF table of contents for medical device applications guidance

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	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 1}	4^{Footnote 1}	4^{Footnote 1}	4^{Footnote 1}	4^{Footnote 1}
Screening period
Regulatory screening	12^{Footnote 1}	5^{Footnote 1}	5^{Footnote 1}	4^{Footnote 1}	12^{Footnote 1}
Technical screening	n/a	7^{Footnote 1}	7^{Footnote 1}	n/a	n/a
Administrative processing	3^{Footnote 1}	3^{Footnote 1}	3^{Footnote 1}	3^{Footnote 1}	3^{Footnote 1}
Target performance standard^{Footnote 2}	15^{Footnote 2}	n/a	n/a	n/a	15^{Footnote 2}
Review period
Review 1^{Footnote 3}	n/a	57^{Footnote 1}	72^{Footnote 1}	n/a	n/a
Administrative processing	n/a	3^{Footnote 1}	3^{Footnote 1}	n/a	n/a
Target performance standard^{Footnote 2}	n/a	60^{Footnote 2}	75^{Footnote 2}	n/a	n/a
Review 2^{Footnote 4}	n/a	42^{Footnote 1}	42^{Footnote 1}	n/a	n/a
Administrative processing	n/a	3^{Footnote 1}	3^{Footnote 1}	n/a	n/a
n/a: not applicable Footnote 1 Target timeline (non-cost recovered target) for the application type Return to footnote 1 referrer Footnote 2 Target performance standard (cost recovered target) for application type is the number of days from the date an application is accepted for screening or review to the date of first decision Return to footnote 2 referrer Footnote 3 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 review clock pauses) Return to footnote 3 referrer Footnote 4 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 review clock pauses) Return to footnote 4 referrer

Market authorization time

Market authorization time is the average time it takes 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 and evaluated.

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

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Date modified:: 2025-02-20

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