Labelling under Sections 21 to 23 and Bilingual Labelling

1. Key takeaways

Canadian labelling obligations operate in three layers. Section 21(1) lists 10 items of mandatory content: the device name; the manufacturer’s name and address; the device identifier; the control number for Class III and IV devices; the contents of the package; the word Sterile where applicable; the expiry date; the intended uses and the performance specifications needed for correct use; the instructions for use; and any special storage conditions. Section 23(1) requires that this information be provided at minimum in English or in French. Section 23(3) then provides that for devices sold to the general public, the information in paragraphs 21(1)(a) and (e) to (j) must be provided in both English and French. Reading the three layers together, rather than stopping at the bilingual headline, is what produces an accurate labelling plan and an accurate language budget.

• Section 21(1) prescribes 10 mandatory label content items.
• Section 21(2) requires the information to be clear, legible and prominent, in terms understandable to the intended user.
• Section 23(1): minimum English or French for all devices.
• Section 23(2): the other official language’s instructions for use must be supplied on request without delay.
• Section 23(3): devices sold to the general public require both English and French for paragraphs 21(1)(a) and (e) to (j).
• Sections 21.1 and 21.2: relabelling of non-compliant imported devices within 3 months.

2. Legal basis

The table below lists the provisions of the Medical Devices Regulations relied on in this article, including the amendments that introduced the import relabelling mechanism. All provisions were verified against Justice Laws.

3. Expert insights

Insight 1: the boundary of the bilingual obligation is whether the device is sold to the general public, not whether it is sold in Canada.

This is the most frequent misreading of the Canadian labelling rules. Under section 23(1), a device not sold to the general public must carry its information in either English or French; under section 23(3), a device sold to the general public must carry paragraphs 21(1)(a) and (e) to (j) in both English and French. Writing the rule as a blanket statement that Canada requires bilingual labelling overstates the compliance cost for professional-use devices substantially, and writing it as single-language-for-everything understates it for consumer devices. The determination of public-sale status should therefore be made deliberately, product by product, documented in the labelling plan, and allowed to drive the language scheme rather than a general assumption about the Canadian market.

Insight 2: the supply-on-request obligation of section 23(2) is a third layer.

Under section 23(2), where instructions for use are supplied in only one official language at the time of sale, the manufacturer must supply the instructions in the other official language without delay on the purchaser’s request. This means that even for devices not sold to the general public, the manufacturer must be able to produce the other language version when asked. The obligation is conditional, but the capability behind it cannot be conjured on demand: the other-language version must exist or be producible quickly. Compliance planning should therefore include the other official language version in the documentation set — maintained, versioned and ready for release — even where the routine labelling is single-language, so that a purchaser’s request does not become a translation emergency.

Insight 3: the control number of section 21(1)(d) applies only to Class III and IV.

Under section 21(1)(d), the control number is required only in the case of a Class III or Class IV device. Class I and Class II devices do not fall under this item. The point matters in two directions. For Class III and IV projects, the control number must appear on the label and its generation and traceability should be part of the production control system, since the number is the hook that links a specific unit to its manufacturing records. For Class I and II projects, including the control number is optional rather than required, and the labelling checklist should not demand it as a compliance item where the class does not call for it. Matching the checklist to the class avoids both a missing mandatory item and an unnecessary burden.

Insight 4: importing devices with non-compliant labels has a dedicated channel, but the deadline is 3 months.

Under section 21.1, where a device that is not labelled in accordance with the Regulations is imported for sale, the import may proceed on two conditions: first, the licensed importer or manufacturer must notify the Minister before the import; second, the manufacturer must relabel the device in accordance with the Regulations within 3 months of the day of import and before sale. Under section 21.2, the manufacturer must also ensure the Minister is notified in writing of the name of the person who will relabel the device in Canada. The channel is useful where stock is labelled for another market, but the 3-month clock starts at import, not at the moment the relabelling project is staffed. Treating the deadline as a hard milestone — with the relabelling site, capacity and materials arranged before the goods ship — is the only way the channel works as intended.

4. Practical recommendations

• Use the 10 items of section 21(1) as a line-by-line checklist; no item may be missing.
• Determine public-sale status first, then set the language scheme: if yes, English and French bilingual; if no, English or French plus the other official language version ready to supply on request.
• Add the control number for Class III and IV devices (section 21(1)(d)).
• For devices sold to the general public, place the information on the outer packaging and make it visible under normal conditions of sale under section 22; where packaging is too small, supply it in accompanying instructions.
• Where the section 21.1 channel is used, make the 3-month relabelling deadline a hard milestone.

5. Verification checklist

• □ The label has been checked item by item against the 10 items of section 21(1).
• □ Public-sale status has been determined and the language scheme follows from it.
• □ The control number is present for Class III and IV devices.
• □ Public-facing devices meet the outer packaging and visibility requirements of section 22.
• □ For non-public devices, the other official language instructions for use are ready to supply on request (section 23(2)).
• □ Where the section 21.1 channel is used, the 3-month relabelling deadline is set as a hard milestone.

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