If you are manufacturing or importing medical devices into Canada—or plan to—you need to be aware of a significant change happening in the regulatory landscape. The Health Canada (“HC”) Regulatory Enrolment Process (REP) is becoming the mandatory electronic framework for device submissions in January 2026. 

Being “REP-ready” means more than just familiarizing yourself with templates—it means auditing your entire compliance structure to ensure you don’t have last‐minute surprises when the transition becomes compulsory. At OMC Medical, we help you proactively audit, gap-analyze and implement the necessary changes so your Canadian regulatory entry and ongoing compliance are seamless. 

What is REP & Why It Matters 

Key Facts 

• The REP is a Web-based system of templates and transactions used by Health Canada to receive regulatory information for medical devices.  

• For medical devices, REP became available in a voluntary phase starting July 2024.  

• As of January 2026, it will be mandatory for all relevant submissions for Class II, III and IV devices.

• The templates cover: company enrolment (CO), regulatory transactions (RT), application information (AI) forms and device-details # sheets.

Why You Cannot Delay 

• Non-compliance or last-minute changes may delay approvals or invalidate submissions. 

• Your internal processes must align with the REP structure: data fields, formats (e.g., XML), document retention. 

• Auditing now gives you margin to fix gaps rather than scrambling when the deadline arrives. 

How to Audit Your Canadian Regulatory Compliance

Here’s how OMC Medical recommends you carry out a robust audit for Canadian regulatory compliance ahead of REP. Here’s a step-by-step audit framework for Canada

1. Company Enrolment & Organisation Data 

• Confirm your company is properly registered with HC and you have a Company ID and any required profile updated.

• Review your legal entity, address, manufacturers/distributors in Canada, authorized signatories. 

• Check your internal records match what HC holds (mismatch = amendment, delay). 

2. Device Classification & License History 

• Review each device you sell or plan to sell in Canada: ensure correct classification under Medical Devices Regulations (SOR/98‑282).

• For Class II/III/IV devices, do you hold a valid Medical Device Licence (MDL)? For Class I, ensure appropriate Medical Device Establishment Licence (MDEL). 

• Confirm licences are in force, and all device changes, amendments or transfers have been recorded. 

3. Technical Documentation & Submission Readiness 

• Ensure you hold up-to-date device dossiers, risk management files (e.g., ISO 14971), clinical evidence, labeling (English & French) as required. 

• Map your documentation to the new REP submission templates: e.g., Device Details spreadsheet, Regulatory Transaction template.

• Validate you have a process for amendments and minor changes (because REP covers those too). 

• Check that your QMS (for higher risk devices) is aligned with ISO 13485 and, if needed, MDSAP.  

4. IT & Data Infrastructure 

• Ensure your submission-ready documents are stored in formats acceptable for REP (often XML, CSV, structured data). 

• Establish version control and audit trail for your files (HC may request this). 

• Train your team on the REP submission process (especially if using the Common Electronic Submission Gateway).  

5. Post-Market Surveillance & Change Management 

• Post-market obligations (incident reporting, corrective actions, licensing amendments) must be consistently managed. 

• Audit your change-control system: any change to device design, labeling, manufacturing must trigger internal review and possibly regulatory submission. 

• Ensure you have a defined timeline and responsibility for amendments aligned with REP expectations. 

6. Gap Analysis & Action Plan 

• At OMC Medical we perform a gap-analysis workshop: we compare your current state vs REP readiness state. 

• We provide a tailored Action Plan with timelines, owners, and milestones to close each gap. 

• Example deliverables: checklist, risk register, submission calendar, training schedule. 

Common Pitfalls We See (and How to Avoid Them) 

• Mismatch of company details: Many companies start REP but company registration doesn’t align – causing submission rejection. 

• Outdated documentation: Using old versions of templates or not updating legacy dossiers to new standards. 

• Underestimating IT/data burden: REP demands structured data; if you treat it like “just another form”, you’re likely to incur delays. 

• Neglecting change-control: After getting initial license, many firms ignore tracking device changes – REP covers amendments too. 

• Waiting too late: With mandatory status from Jan 2026, starting late means less buffer for correction or resubmission. 

Why Work with OMC Medical? 

At OMC Medical, we specialise in supporting global MedTech companies through the full Canadian regulatory lifecycle: from market strategy, classification, documentation, REP submission readiness and post-market compliance. 

• We help you become REP-ready ahead of the deadline, avoiding last-minute surprises. 

• Our team has hands-on experience with HC’s systems, templates and submission practices. 

• We provide end‐to‐end services: audit, gap-analysis, training, submission support, post-market monitoring. 

• We speak your language: whether you’re a large manufacturer or a startup, we tailor our support to your size, geography and device risk class. 

Partnering with us means your Canadian regulatory compliance becomes a strategic advantage, not a bottleneck. 

Next Steps for You 

1. Book a 30-minute consultation with OMC Medical to assess your current REP-readiness. 

2. Conduct the audit using our structured framework above. 

3. Develop the Action Plan, assign owners and set deadlines. 

4. Monitor progress monthly and adjust as you go – aim to complete well before Jan 2026. 

Summary 

The January 2026 REP deadline is real and firms delaying the audit are exposing themselves to risk: delayed market entry, compliance issues, rejections. By auditing your company and devices now, aligning with HC templates, managing documentation and change-control, you position yourself for smooth Canadian market access and longer-term compliance success. 

At OMC Medical, we’re ready to support you every step of the way. Let’s ensure you’re not just “ready” — you’re REP-ready. 

For more information or to schedule your readiness audit, contact us at info@omcmedical.com or visit omcmedical.com.