Health Canada has released a new version of its Guidance on managing applications for medical device licences (MDLs), published 21 November 2025 and coming into force on 2 February 2026. This version replaces the 2020 “Management of Applications for Medical Device Licences” guidance and will apply to all MDL applications and reconsideration requests that are in progress on or after the effective date.
The guidance does not change the underlying Medical Devices Regulations, but it does significantly reshape how Health Canada manages licence applications – especially timelines, communication on deficiencies, and reconsideration of negative decisions. For manufacturers planning (or maintaining) market access in Canada, this document is now the playbook for navigating Class II–IV licensing.
1. WHICH HEALTH CANADA’S NEW MDL APPLICATIONS ARE AFFECTED?
The guidance applies to Class II, III and IV medical devices submitted under Part 1 of the Medical Devices Regulations.
- New and amendment Class II MDL applications
- New and amendment (significant change) Class III applications
- New and amendment (significant change) Class IV applications
- Minor change applications
- New and amended private label applications
It does not apply to devices handled under Part 1.1 (urgent public health need authorisations). Those follow a separate guidance.
So, any manufacturer holding or seeking a Class II–IV licence – including private labelers – must align their processes with this new framework.
2. MANDATORY ELECTRONIC FILING VIA REGULATORY ENROLMENT PROCESS (REP) AND COMMON ELECTRONIC SUBMISSIONS GATEWAY (CESG)
A major procedural clarification is that all new and amendment MDL applications and related regulatory transactions (including responses, unsolicited information, and withdrawal requests) must be filed using:
- the Regulatory Enrolment Process (REP), and
- submitted through the Common Electronic Submissions Gateway (CESG).
This means manufacturers (or their Canadian regulatory representatives) need to:
- Be onboarded and technically ready for REP and CESG
- Follow Health Canada’s IMDRF Table of Contents (ToC) structure, including foldering and naming conventions, which are checked at administrative screening.
Any legacy workflows that rely on other submission channels will need updating before February 2026.
3. NEW AND CLARIFIED TIMELINES – AND THE CONCEPT OF “MARKET AUTHORIZATION TIME”
3.1 Target timelines and performance standards
The guidance sets out a detailed timeline matrix by application type. Table 1 on page 12 summarises administrative screening, regulatory/technical screening, review periods and performance standards for Class II–IV, minor changes and private label applications.
Key elements include:
- Administrative screening
- Aim: 4 days for most MDL applications to check completeness, fees, file structure, etc.
- Aim: 4 days for most MDL applications to check completeness, fees, file structure, etc.
- Regulatory screening
- Class II and private label: 12 days (plus 3 days admin processing).
- Class III/IV significant change: 5 days prior to technical screening.
- Class II and private label: 12 days (plus 3 days admin processing).
- Technical screening (Class III & IV only)
- 7 days to verify the required scientific evidence is present.
- 7 days to verify the required scientific evidence is present.
- Review performance standards (from Screening Acceptance Letter)
- Class III: 60 days to first decision, including admin processing.
- Class IV: 75 days to first decision.
- Class III: 60 days to first decision, including admin processing.
These are targets, not guarantees, but they are crucial benchmarks for planning launch dates and resourcing.
3.2 Market authorization time and extension requests
A new concept “market authorization time” is introduced as the average time from receipt of the application to licence issuance, covering all stages, including time taken by the manufacturer to respond to deficiency letters.
Manufacturers can request extensions to respond to screening deficiency or additional information letters, but:
- The request must go through REP.
- It must provide a justification and a new timeline that does not exceed the original response duration.
- Approval is case-by-case and not guaranteed.
Any approved extension counts toward the overall market authorization time, potentially delaying access to the Canadian market.
4. SCREENING: ADMINISTRATIVE, REGULATORY AND TECHNICAL
4.1 Administrative screening
At this first gate, Health Canada checks:
- Fee form completeness
- File format, folder structure and naming (IMDRF ToC)
- Basic administrative elements
If the application is administratively complete, it receives an application number and moves to regulatory screening; Class II, private label and Class III/IV significant change applications are notified at this point. For new/amendment Class II and private label applications, 100% of the fee is charged once the file passes this step.
If administrative gaps exist, Health Canada issues a request for outstanding information with 10 days to respond; failure leads to a rejection letter and no fee is charged.
4.2 Regulatory screening
Here, Health Canada validates:
- Device risk classification
- Licence application type
- Valid QMS certification
- Device labelling
- Non-clinical regulatory support (for example, certificates, declarations)
Health Canada can issue clarification requests for minor points (e.g., cross-links between licences). Response times can be as short as 2 days, and the administrative clock does not stop. Failure to respond adequately can escalate to a deficiency letter.
4.3 Technical screening (Class III/IV)
For Class III/IV new or significant change applications, Health Canada verifies that all required scientific evidence (bench, pre-clinical, clinical, software validation, etc.) is present before proceeding to full review.
Where major regulatory deficiencies exist (e.g., misclassification, unsuitable QMS certificate), a screening deficiency letter (SDL) can be issued even before technical screening.
5. MANAGING DEFICIENCIES: SDLS AND TWO TYPES OF AI LETTERS
5.1 Screening deficiency letters (SDLs)
SDLs can be issued for Class II, III, IV, private label and minor change applications that are incomplete or inconsistent during screening. The manufacturer typically has:
- 15 days to respond for most application types
- A new screening period that restarts once an administratively complete response is received
Failure to respond, or providing incomplete information, may lead to a rejection letter (screening stage), after which the manufacturer can refile, but the application is treated as new and fees apply again.
5.2 Additional information (AI) letters during review
During the scientific review of Class III/IV applications, Health Canada now clearly distinguishes between two types of Additional Information letters, both of which stop the review clock until a response is received:
- AI–Deficiency (AI-D)
- Used when the file is incomplete or deficient based on the submitted evidence.
- The manufacturer usually has 60 days to respond.
- Typically no more than two AI-D letters are issued, though more are possible in specific circumstances.
- Used when the file is incomplete or deficient based on the submitted evidence.
- AI–Noncompliance (AI-N)
- Used when there are significant deficiencies or omissions that hinder further review, or if a false or misleading statement is identified.
- Response time is only 10 days.
- Multiple AI-N letters are possible and can be followed by AI-D letters or a refusal.
- Used when there are significant deficiencies or omissions that hinder further review, or if a false or misleading statement is identified.
If the manufacturer does not respond adequately to AI letters, Health Canada may issue a refusal letter, which cites the specific reasons for refusing to issue or amend the licence.
6. UNSOLICITED INFORMATION, PAUSE-THE-CLOCK AND WITHDRAWALS
6.1 Unsolicited information
Manufacturers may submit unsolicited updates related to:
- Regulatory status of the device in other jurisdictions
- Updated information on safe use, including safety-related labelling and problem reports sent to other authorities
This does not cover significant changes to the device or its scope; such changes require a new or amendment application.
This is a key interface with post-market surveillance (PMS): updated labelling and safety information generated from PMS activities can be proactively shared and may support ongoing or future reviews.
6.2 Pause the clock
“Pause the clock” is now formally defined but strictly limited to two scenarios:
- Combination products: where the device portion is positively assessed but the drug component review is still ongoing.
- Linked applications with different timelines: e.g., a Class III implant and its Class II delivery system.
In both cases, Health Canada notifies the manufacturer when the clock is paused and when it resumes. This is not a general tool for gaining extra response time; it is controlled by Health Canada, not requested by the manufacturer.
6.3 Withdrawal
Manufacturers can withdraw at screening or review by filing a withdrawal request via REP. Acknowledgement is issued, and the application can be refiled later as a new application. Fee consequences differ by stage (e.g., 10% of the fee may be charged for certain withdrawn Class III/IV files after an SDL has been issued).
7. REFILLING AND RECONSIDERATION OF NEGATIVE DECISIONS
7.1 Refiled applications
The guidance clarifies when you may cross-reference previous data:
- Within 6 months of a refusal or withdrawal: you can submit only the requested or missing material, cross-referencing earlier content, provided you certify that it is unchanged and clearly distinguish new vs. old information.
- After 6 months, or after a rejection at screening: you must file a completely new application without cross-referencing prior submissions.
All refiled applications are fully subject to current guidance, policies and fees at the time of refiling.
7.2 Reconsideration process
For negative decisions (rejection or refusal), manufacturers may ask for reconsideration under section 38(3) of the Regulations.
Key features of the revamped process:
- Requests must be filed via REP within 30 days of the decision, and can only rely on information that was already available to Health Canada when the original decision was made (no new data, studies or revised labelling).
- Requests are screened within 15 days to confirm eligibility.
- The Director General selects either:
- an internal review (written submissions, with or without a meeting), or
- an external expert panel review in exceptional, highly specialised cases.
- an internal review (written submissions, with or without a meeting), or
- Target timelines (from request to reconsideration decision):
- Internal, written only: 50 days
- Internal + meeting: 85 days
- External panel + meeting: 140 days
- Internal, written only: 50 days
Outcomes may uphold, partially amend or fully amend the original decision, with clear follow-on actions (e.g., immediate licence issuance, or reinstatement of the application into the normal review queue).
8. WHAT THIS MEANS FOR MANUFACTURERS: PRACTICAL IMPLICATIONS
For medical device manufacturers – and private labelers – targeting Canada, the new guidance has several concrete implications:
- Prepare for REP/CESG now
- Ensure your regulatory team or Canadian representative can submit via REP and CESG and can structure dossiers according to the IMDRF ToC.
- Ensure your regulatory team or Canadian representative can submit via REP and CESG and can structure dossiers according to the IMDRF ToC.
- Build robust internal timelines and trackers
- Calendars must track short response windows:
- 10 days for administrative fixes
- 15 days for SDLs
- 60 days for AI-D and 10 days for AI-N
- 10 days for administrative fixes
- Missing these deadlines can quickly result in rejection or refusal, forcing a full refiling.
- Calendars must track short response windows:
- Tighten application quality (classification, labelling, QMS evidence)
- Misclassification, weak labelling or gaps in QMS certification now clearly trigger SDLs or AI-N letters.
- Strong pre-submission planning (and, where needed, pre-submission meetings with Health Canada) will reduce iterations and overall market authorization time.
- Misclassification, weak labelling or gaps in QMS certification now clearly trigger SDLs or AI-N letters.
- Link PMS and pre-market dossiers
- PMS outputs – safety data, field actions, labelling updates – should be ready to feed both:
- unsolicited safety information during review, and
- amendment applications when the change is significant.
- unsolicited safety information during review, and
- PMS outputs – safety data, field actions, labelling updates – should be ready to feed both:
- Document your rationale for reconsideration
- If you anticipate challenging a negative decision, keep clear internal records of:
- how you interpreted the data,
- your risk–benefit assessment, and
- how these align with the materials originally submitted.
- how you interpreted the data,
- Remember: reconsideration is not an opportunity to introduce new data.
- If you anticipate challenging a negative decision, keep clear internal records of:
CONCLUSION
Health Canada’s 2025 guidance on managing MDL applications goes beyond a cosmetic update, introducing clearer timelines, stricter handling of deficiencies, and a more transparent reconsideration process, all built around mandatory electronic submissions and IMDRF-aligned dossiers. For manufacturers, this means focusing on strong, high-quality initial submissions, being ready to respond quickly and completely to SDL and AI letters, and using PMS insights to refine labelling and change strategies. Doing so will help reduce time-to-licence and ultimately accelerate access to the Canadian market.