On November 21, 2025, Health Canada issued a revised document outlining the management process for medical device license (MDL) applications bases on device classification.
The list of MDL applications that can be submitted is as follows
- New and amendment applications for Class II
- New and amendment (significant change) applications for Class III
- New and amendment (significant change) applications for Class IV
- Applications for minor changes, etc.
The main changes to the guidelines are as follows
1) Appendices – Process flow diagrams for the application management and reconsideration processes have been added.
2) Reconsideration Process – If a negative decision is issues for an MDL application, the manufacturer can request a reconsideration of the decision.
3) Deficient Applications (AI letter) – Information regarding additional information requests (AI deficiency letter and AI non-compliance letter) has been added.
4) Withdrawal letter (Screening process) – The manufacturer can withdrawal an MDL application at any time during the screening process using the Regulatory Enrolment Process (REP)
5) Screening Deficiency Letter (SDL) – If deficiencies are found during the validity review of Class II to IV applications or minor change applications, a Screening Deficiency Letter (SDL) will be issues.
6) Clarification Requests (Regulatory Screening) – During regulatory screening, clarification or additional details may be requested for any minor information provided in the application. If the requested information is not submitted within the specified timeframe, or if the information is incomplete or deficient, an SDL will be issued.
7) Market Authorization Time – Refers to the average time for the receipt of an MDL application to the issuance of the MDL. If additional information is requested via an SDL or AI letter, and the requested information cannot be provided within the specified timeframe, an extension may be requested.
8) How to submit applications – Applications must be submitted through the REP.
Please refer to the attached document below.
If you have any questions about medical devices,
please contact us with the below.
ra@jnmglobal.net
info@jnmglobal.net