Get Your Medical Device Approved in Canada — Without the False Starts

If your company imports, distributes, or manufactures medical devices for the Canadian market, you are legally required to hold a Medical Device Establishment Licence (MDEL) before any device reaches a customer. There is no grace period — selling without one exposes you to enforcement action and product seizure.

We manage the entire MDEL process so you're not learning Health Canada's documentation standards through trial and error:

• Determine whether your activities (import, distribute, or manufacture) require an MDEL
• Build or review your Quality Management System against ISO 13485:2016
• Prepare and submit your full MDEL application package
• Act as your regulatory correspondent with Health Canada during review
• Manage annual licence renewal so you never lapse out of compliance

Health Canada offers meaningful fee reductions for qualifying small businesses — but you must apply for small business status before you submit your application. Apply after, and you pay full price with no way to recover the difference.

You may qualify if your company has fewer than 100 employees, or annual gross revenue between $30,000 and $5 million CAD. If you qualify:

• Your first-ever Pre-market submission can be completely free
• 50% reduction on all future Pre-market Evaluation fees
• 25% reduction on Right to Sell fees
• 25% reduction on your annual MDEL fee

We confirm your eligibility, file your small business status application correctly, and time your submission so the reduction actually applies — a step many companies get wrong and lose the discount entirely.

Not every company wants ongoing consulting — some teams just need the right documentation framework to implement compliance themselves. Our Medical Device Importer SOPs & Forms Toolkit gives you exactly that.

• Core and Expanded toolkit options depending on your scope
• Standard Operating Procedures aligned to importer obligations under the MDR
• Supporting forms and logs ready for immediate use
• Digital delivery — implement on your own timeline

This is a self-purchase option for teams that are documentation-capable but want a proven framework rather than building from a blank page.

Class I devices need no licence. Everything above that — Class II, III, and IV — requires a product-specific Medical Device Licence before you can legally sell in Canada. The class your device falls into determines your evidence requirements, fees, and review timeline:

• Class II — lower risk devices, 15 calendar day review target
• Class III — moderate-to-high risk, 75 calendar day review target
• Class IV — highest risk devices, 90 calendar day review target

Getting your classification wrong is one of the most common — and most expensive — mistakes companies make. We confirm your class against Health Canada's risk-based rules before anything is submitted, then manage your full MDL application from documentation through to licence grant.

If your product is software that diagnoses, treats, monitors, or otherwise influences a clinical decision, it likely falls under Software as a Medical Device (SaMD) rules — a category Health Canada treats distinctly from physical devices.

• Assess your software's intended use and clinical risk level
• Determine the correct SaMD classification and licensing pathway
• Build inclusion and exclusion criteria specific to your software's function
• Manage the registration and licensing process with Health Canada

SaMD classification mistakes are common because the logic differs from hardware devices — we've worked through this with multiple software-based clients and know where reviewers focus their scrutiny.

Many companies want to sell a medical device under their own brand without manufacturing it themselves or holding their own MDL. This is possible — but only if it's structured correctly through the original manufacturer's existing licence.

• Confirm whether your private label arrangement can rely on the manufacturer's existing MDL
• Put the correct agreements and documentation in place between you and the manufacturer
• Ensure your labelling and branding meet Health Canada's requirements for private label products
• Identify when your arrangement instead requires its own licensing or MDEL

Get this structure wrong and Health Canada can treat your private label sales as unlicensed distribution — even if the underlying device is fully approved. We confirm the right structure before you launch, not after.