Private Label Medical Device Licensing

1. Key takeaways

A private label medical device is a device that is identical in every respect to a device already licensed, and that is labelled only with the name and address of another manufacturer, together with the device name and identifier under which that other manufacturer intends to sell it — whether under its own name, or under a trade-mark, design, trade name or other name or mark that it owns or controls. Its licence application and amendment application fee is 179 CAD (effective from 2026-04-01). The pathway is narrow by design: because the device must be identical in every respect, the only permitted variation is the labelling layer, and the low fee reflects a review focused on confirming that identity rather than reassessing the device.

• Private label status requires the device to be identical in every respect to a licensed device; only the labelling may differ.
• The licence application and amendment application fee is 179 CAD from 2026-04-01.
• The fee applies across Class II, III and IV — it is not tiered by device class.
• The private label distributor falls within the manufacturer definition and must hold its own licence.
• The pathway depends on the continued validity of the underlying licence.

2. Legal basis

The table below lists the sources for the private label pathway: the definition clause and fee item in the fee order, the current amount on the Health Canada fee page, and the manufacturer definition in the Regulations that brings the private label distributor within the licensing obligation.

3. Expert insights

Insight 1: The core of the private label definition is identity in every respect.

The definition clause of Schedule 8 uses the wording “identical in every respect”. Differences are permitted only at the labelling level: the other manufacturer’s name and address, and the device name and identifier. Any difference in technology, materials, processes or intended use makes the private label pathway unavailable. This is a demanding test, and it should be applied literally: the question is not whether the devices are equivalent, comparable or substantially similar, but whether they are the same device in every parameter. A device that differs in even one technical characteristic must go through the ordinary licensing route, with the fees and evidence expectations of its class.

Insight 2: The 179 CAD fee corresponds to reusing existing review conclusions.

The private label fee item (179 CAD) sits far below Class II (643 CAD), Class III (14,163 CAD) and Class IV (30,713 CAD), and it is not tiered by device class — the wording of item 10 applies the same amount to a “Class II, III or IV licence application … private label device”. This reflects that the review workload of the pathway is concentrated on confirming identity, not on re-examining the device. Whether the underlying device is a Class II toothbrush or a Class IV implant makes no difference to the fee, because what is being reviewed is the relationship between two identical devices and the labelling change, not the device itself.

Insight 3: The private label distributor falls within the manufacturer definition and must hold its own licence.

Under the Section 1 manufacturer definition of the Medical Devices Regulations, a person who sells a device under their own name, or under a trade-mark, design, trade name or other name or mark that they own or control, and who assumes the corresponding responsibility, is a manufacturer — regardless of whether that work is done by the person themselves or on their behalf by someone else. A private label distributor therefore cannot argue that it is merely a seller. The obligation to hold the licence, and the responsibilities that come with it, attach to the entity that puts its name on the product.

Insight 4: The private label pathway depends on the continued validity of the existing licence.

A private label licence is built on the premise that a licence has already been issued for the device. If the underlying licence is suspended or cancelled, the stability of the private label licence is affected accordingly, and this dependency must be reflected in the agreements and in supply chain management. The private label holder is, in effect, exposed to the regulatory health of another party’s licence, which makes contractual allocation of maintenance obligations and change notification duties a substantive part of the pathway rather than an optional commercial detail.

4. Practical recommendations

• Build an identity verification checklist first: compare technical parameters, materials, processes, intended use and performance specifications item by item against the base device.
• Keep differences at the labelling level only; route any substantive difference through the ordinary licensing pathway instead.
• Budget at 179 CAD, noting that it is not tiered — the amount applies to private label devices across Class II / III / IV.
• Lock the maintenance obligations for the base licence and the change notification obligations into the agreements.
• Treat the private label distributor as a manufacturer and configure incident reporting and recall procedures accordingly.

5. Verification checklist

• □ The item-by-item identity verification checklist against the base device has been completed
• □ Differences exist only at the labelling level (name and address, device name and identifier)
• □ The base licence has been confirmed as valid, and not suspended or cancelled
• □ The budget has been prepared at 179 CAD (regardless of class)
• □ The agreements lock in the base licence maintenance and change notification obligations
• □ Incident reporting and recall procedures have been configured with the private label distributor treated as a manufacturer

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