Class I Devices and the MDEL Requirement

1. Key takeaways

In Canada, Class I devices do not require a Medical Device Licence (MDL). However, to import or sell a Class I device, the manufacturer, the importer, and the distributor must each hold a Medical Device Establishment Licence (MDEL). The only exemption is that a manufacturer which imports or sells solely through a Canadian company holding an MDEL is itself exempt from the MDEL requirement. In short, what Class I manufacturers avoid is the product licence, not the establishment licence.

• Class I devices need no MDL, but the establishment licence obligation continues to apply across the supply chain.
• The manufacturer exemption depends on the word solely: any direct import or direct sale removes the exemption.
• Class I sits among four licence-exempt and fee-exempt categories on the Health Canada fees page.
• Written procedures for complaints, recalls, and reporting are a precondition for obtaining an MDEL.

2. Legal basis

The table below lists the instruments relied upon in this article, together with the relevant provisions, dates, and official sources.

3. Expert insights

Insight one: the statement that Class I needs no licence is only half right.

The official Health Canada wording is: “Class I medical devices do not require a medical device licence. However, to import or sell a Class I device, a medical device establishment licence (MDEL) is required for: manufacturers, importers, distributors.” What is missing for Class I is the MDL, not the full set of licences. A Class I project that treats the absence of an MDL as the absence of all regulatory work will overlook the establishment-level obligations that continue to attach to every company that manufactures, imports, or distributes the device within Canada.

Insight two: the manufacturer exemption from the MDEL has explicit conditions.

The official Health Canada wording is: “Manufacturers that import or sell solely through a company that holds an MDEL are exempt.” The word solely is the decisive element of the condition. As soon as a manufacturer also imports on its own account or sells directly to the market, the exemption fails, and the manufacturer must hold an MDEL in its own right. Each sales channel must therefore be mapped before the exemption is claimed, because the exemption is tested against the whole of the company’s activity, not against its principal channel. A manufacturer that sells through a licensed importer on the main account but also ships demonstration units or direct orders itself should either route those transactions through the licensed channel as well or obtain an MDEL, since a single non-conforming channel is enough to break the exemption.

Insight three: Class I is one of four licence-exempt and fee-exempt categories.

According to the Health Canada fees page, the four categories exempted from the device licence requirement, and therefore from the fees, are: Class I devices, custom-made devices, devices for special access, and investigational testing devices involving human subjects. Exemption from the MDL, however, is not exemption from post-market obligations. The incident reporting duties, the record-keeping duties, and the establishment licence framework all continue to operate for these categories, and a fee-free pathway is not a supervision-free pathway.

Insight four: the precondition for obtaining an MDEL is written procedures.

The official Health Canada wording states that to obtain an MDEL, an establishment must have written procedures demonstrating that it can respond to complaints and carry out a recall where necessary; manufacturers and importers must also have procedures for reporting recalls and serious device problems to Health Canada. This is the preparation item that Class I companies most often overlook, because the class label suggests a light regime. In practice the procedure files are what the application and any subsequent inspection will be tested against. A Class I company should treat the procedures as the substance of its application: the written documents, the records that show they are followed, and the evidence that staff know how to use them together form the picture that Health Canada reviews when the establishment licence is examined.

4. Practical recommendations

• Structure the Class I project budget so that it contains no MDL application fee, but does contain the MDEL review fee of 5,519 Canadian dollars, effective from 2026-04-01.
• Determine whether the manufacturer qualifies for the exemption of selling solely through a company holding an MDEL, and verify the sales channels item by item.
• Establish the three sets of written procedures early: complaint handling, recall execution, and reporting of serious device problems.
• Although Class I devices are exempt from the MDL, the incident reporting obligations of sections 59 to 61 still apply, so the reporting process should go live at the same time as the market entry work.
• Perform the Annual Licence Review (ALR) before April 1 each year; the Class I status of the product does not remove this duty.

5. Verification checklist

• □ It has been confirmed that the product is Class I and no MDL application is required
• □ It has been determined whether the manufacturer, the importer, and the distributor each require an MDEL
• □ If the manufacturer exemption is claimed, every sales channel has been checked to confirm it goes solely through a company holding an MDEL
• □ The three written procedure sets, complaint handling, recall execution, and serious problem reporting, have been established
• □ The MDEL review fee of 5,519 Canadian dollars has been included in the budget
• □ The Annual Licence Review (before April 1) has been entered in the annual calendar

Regulatory information verified as of October 28, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Canadian market. Our team manages Health Canada Medical Device Licence and MDEL applications, prepares risk-classified dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com