GRZAN Canada Medical Device Registration and Post-Market Compliance Services

1. Key takeaways

GRZAN’s medical device registration service for Canada covers six nodes: classification determination and analysis of the application of Schedule 1 rules, MDSAP certification coordination, establishment licence (MDEL) application and annual maintenance, Medical Device Licence (MDL) dossier preparation and submission, labelling and import arrangements, and post-market compliance management. The Canadian market is delivered jointly by the GRZAN registration team and licensed local partners in Canada.

• Classification determination corresponds to section 6 and Schedule 1; MDSAP coordination corresponds to the Class II–IV system evidence requirement (practical estimate: mandatory from 2019-01-01).
• The MDEL node corresponds to sections 44 to 46.1; the MDL node corresponds to sections 32 to 36.
• Labelling and import arrangements correspond to sections 21 to 23 and section 44(3).
• Post-market compliance corresponds to sections 52, 58, 58.1, 59 to 61, and 63.2, 64, 65.
• Official fees are adjusted annually (MDL application fees of 643 / 14,163 / 30,713 CAD, MDEL 5,519 CAD, right to sell fee 460 CAD, all from 2026-04-01); GRZAN quotes official rates and statutory timelines, and does not offer approval promises or issuance-time guarantees.
• The remediation window before 2026-12-14 under SOR/2026-110 is currently the most urgent work item for existing MDEL holders.

2. Legal basis

Every node of the service maps onto a specific set of provisions, so the service description can be verified provision by provision. The table below lists the instruments relied on across the six nodes.

3. Expert insights

This article describes how the service is structured and why it is structured that way. The insights below explain the delivery model, the mapping of the six nodes to legal duties, and the rules GRZAN follows on fees, timelines and the 2026 remediation window.

Insight 1: GRZAN operates a model of licensed local partner coordination in Canada.

GRZAN operates its own entities in Singapore, Malaysia, Thailand, Indonesia, Vietnam and the Philippines, and can directly act as the local licence holder, importer and authorised representative in those markets. In Canada, because the MDEL and the import leg must be carried by a party operating in Canada, we complete the establishment licence and import arrangements through licensed local partners in Canada, while the GRZAN registration team carries out all classification determination, dossier preparation and project management work. The client therefore gets a single accountable team for the technical and regulatory work, and a compliant local position for the establishment and import duties.

Insight 2: the service chain is designed around six nodes, each corresponding to a statutory duty.

Classification determination corresponds to section 6 and Schedule 1; MDSAP coordination corresponds to the system evidence requirement for Class II–IV devices (practical estimate: mandatory from 2019-01-01); the MDEL corresponds to sections 44 to 46.1; the MDL corresponds to sections 32 to 36; labelling and import correspond to sections 21 to 23 and section 44(3); and post-market compliance corresponds to sections 52, 58, 58.1, 59 to 61, and 63.2, 64, 65. Because the mapping is explicit, the client can verify at any time which regulatory provision each work package serves.

Insight 3: fees and review periods are not offered as commitments.

Official fees are adjusted annually (MDL application fees of 643 / 14,163 / 30,713 CAD, MDEL fee of 5,519 CAD, right to sell fee of 460 CAD, all applying from 2026-04-01), and review periods are affected by requests for supplementary information and clarification. What we provide in project documents is the official rates and the statutory timelines; we do not provide approval promises or guarantees of issuance dates. This keeps the client’s expectations aligned with what the regulator actually controls.

Insight 4: the remediation window before 2026-12-14 is the most urgent current time point.

SOR/2026-110 comes into force on 14 December 2026. Existing MDEL holders must complete, before that date, the supplier information inventory and the five groups of documented procedures (52(3), 58, 58.1, 59(3)(4), 61.2(4)), with operating records left behind. This is the work item we schedule first for existing clients, because the deadline is fixed and the workload is measurable.

4. Practical recommendations

• At project initiation, run the classification determination first and output a classification and Schedule 1 rule application analysis, as the input to all subsequent work.
• For Class II–IV projects, schedule MDSAP certification in parallel with the MDL application; MDSAP is the first gate.
• Build the dossier in four parts: what the product is; on what basis it is safe and effective; how the quality system assures it; how the labelling presents it.
• For labelling, first determine whether the device is sold to the general public, then decide the English and French bilingual scheme.
• Bring the five post-market lines (ALR, incident reporting, recalls, documented procedures, supplier information) live before the first shipment.
• Existing MDEL holders should complete SOR/2026-110 remediation before 2026-12-14.

5. Verification checklist

• □ The classification and Schedule 1 rule application analysis has been completed
• □ The MDSAP certificate is valid and its audit scope covers Canada (Class II–IV)
• □ The Canadian importer’s MDEL is valid
• □ The four-part MDL dossier structure is complete
• □ The labelling language scheme has been determined under section 23
• □ The five post-market lines are live
• □ SOR/2026-110 remediation has been completed before 2026-12-14

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