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Earlier capture
Draft guidance on managing applications for medical device licences: Overview - Canada.ca
Apr 19, 2025
legacy-hc-2025-04-21
ID 178276
Later capture
Guidance on managing applications for medical device licences: Overview - Canada.ca
Jan 2, 2026
hc-20260101
ID 428987
updated2 sections changed; 1 added; 1 removed
2 sections changed1 added1 removed+19 / -11 linesChange ratio: 17%
--- +++ @@ -1,22 +1,26 @@-Draft guidance on managing applications for medical device licences: Overview+Guidance on managing applications for medical device licences: Overview Overview Filing applications Screening process Review process Refiled applications Reconsideration process-Draft date:-February 20, 2025 (version 5)+Appendices+Date published:+November 21, 2025 (version 5) Replaces: Guidance Document: Management of Applications for Medical Device Licences (April 1, 2020)+This guidance document will take effect on February 2, 2026. Any medical device licence applications in progress on or after that date, including requests for reconsideration, will follow this guidance. Document change log Date Location (section, paragraph) Nature of and reason for change-February 20, 2025+November 21, 2025+Appendices+Included maps for the application management process and the reconsideration process. Reconsideration process-Updated to reflect the revamped reconsideration process and include a reconsideration process map and request for reconsideration form.+Updated to reflect the revamped reconsideration process. Deficient applications - additional information letter Included information on the different types of additional information letters. Withdrawal letter (under Screening process)@@ -25,6 +29,10 @@ Adjusted response times to screening deficiency letters to ensure consistency across applications. Clarification request (under Regulatory screening) Included information on clarification requests during regulatory screening.+Market authorization time+Added information on market authorization time and extension requests.+How to send applications+Included information on the requirement to file applications using the Regulatory Enrolment Process. Full document Edited to make clearer and enhance flow and readability. April 1, 2020@@ -47,11 +55,11 @@ Pause the clock Included information resulting from "pause the clock" consultation. Download the alternative format-(PDF format, 706 KB, 37 pages)+(PDF format, 706 KB, 42 pages) Organization: Health Canada Published:-2025-02-20+2025-11-21 On this page Purpose Scope and application@@ -72,8 +80,9 @@ new and amendment private label applications Learn more: Medical device application forms-Guidance for the interpretation of significant change of a medical device-It does not apply to applications for authorizations submitted under Part 1.1 of the regulations.+Guidance on how to interpret 'significant change' of a medical device+It does not apply to applications for authorizations submitted under Part 1.1 of the regulations. For information on Part 1.1, consult:+Guidance on medical devices for an urgent public health need Policy objectives Our goal in providing guidance on the processes for managing MDL applications is to ensure consistency and predictability. For this reason, we have included target timelines and performance standards at key steps along the way. Note about guidance documents in general@@ -82,5 +91,4 @@ As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, effectiveness or quality of a medical device. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented. This document should be read along with the relevant sections of the regulations and other applicable guidance documents. Page details-Date modified:-2025-02-20+2025-12-09