Class III Licence Pathway for Near Patient IVDs

1. Key takeaways

Near patient in vitro diagnostic devices (near patient IVDs) carry a separate fee item in Schedule 8 of the Order Respecting Fees for Drugs and Medical Devices: the licence application fee for a Class III near patient IVD is 30,169 CAD (effective from 2026-04-01), significantly higher than the 14,163 CAD charged for an ordinary Class III device and close to the 30,713 CAD charged for Class IV. The consequence for planning is direct: a near patient IVD project cannot be costed on the general Class III tier, and the review intensity behind that fee should be expected to sit at the Class IV level even though the classification remains Class III.

• Near patient IVD is a distinct fee item in Schedule 8, not a surcharge on the ordinary Class III tier.
• The Class III near patient IVD application fee is 30,169 CAD from 2026-04-01.
• This sits far above ordinary Class III (14,163 CAD) and nearly at Class IV level (30,713 CAD).
• Whether a device is a near patient IVD is determined in classification, under Part 2 of Schedule 1.
• IVD projects use the classification rules in Part 2 of Schedule 1 and cannot invoke Part 1 rules.

2. Legal basis

The table below lists the sources for the near patient IVD fee position: the current fee page entries, the fee order itself, the comparative tiers for ordinary Class III and Class IV, and the classification rules that determine whether a device is an IVD and where it lands.

3. Expert insights

Insight 1: Near patient IVD is a standalone fee item in the schedule, not a surcharge on ordinary Class III.

Under the Health Canada fee page, item 3 of Schedule 8 (Class III, other devices) and item 4 (Class III, near patient IVD) are two parallel fee items, with amounts of 14,163 CAD and 30,169 CAD respectively. Enterprises cannot estimate the cost of a near patient IVD using the general Class III tier. The distinction is not cosmetic: the two items exist because the review burden differs, and picking the wrong item in the budget produces a number that is off by more than double. Any costing exercise for a Class III IVD should begin by establishing which of the two items the device actually falls into.

Insight 2: The fee level, close to Class IV, reflects the scale of review resources invested.

Class III near patient IVD is 30,169 CAD; Class IV is 30,713 CAD — a difference of only 544 CAD. This closeness is an informative signal rather than a coincidence: the review intensity applied to a near patient IVD should be prepared at the Class IV scale, not at the ordinary Class III scale. A dossier assembled to the lighter Class III expectation will be exposed to follow-up requests when the review actually proceeds at the depth the fee schedule implies. Reading the fee table as a statement about review effort, not only as a price list, keeps the evidence plan aligned with what the review will demand.

Insight 3: The near patient determination belongs to classification, not to the fee stage.

Whether a device is a near patient IVD is determined by the classification rules in Part 2 of Schedule 1; the fee stage simply applies the corresponding fee item according to the classification outcome. A determination error therefore propagates: it produces both a classification error and a fee mismatch at the same time. The near patient character is not a pricing election made at submission — it is a factual and regulatory finding made through the classification analysis, and it should be documented as such, with the reasoning recorded where the classification record is kept.

Insight 4: The classification rules for IVDs and non-IVDs sit in different parts of Schedule 1.

Under Section 6 of the Medical Devices Regulations, Part 1 of Schedule 1 contains the classification rules for non-in vitro diagnostic devices, and Part 2 contains the classification rules for in vitro diagnostic devices. IVD projects must not invoke Part 1 rules. This is a structural boundary that matters in practice: a classification analysis that reaches for a Part 1 rule because it appears to fit an IVD is applying the wrong rule set entirely, and the conclusion it produces has no regulatory standing. Confirming which part governs is the first step of any IVD classification exercise.

4. Practical recommendations

• For IVD projects, determine the classification under the Part 2 rules of Schedule 1 first, and then determine whether the device falls into the near patient fee item.
• Budget the Class III application fee for a near patient IVD at 30,169 CAD; do not use the 14,163 CAD general tier.
• Prepare the evidence and the dossier at the Class IV scale of review intensity.
• Keep the classification conclusion on file in writing, as the basis for fee reconciliation and for managing review expectations.
• For projects submitting around April 1, confirm the applicable annual fee rate according to the actual point in time of submission.

5. Verification checklist

• □ The IVD classification has been determined under the Part 2 rules of Schedule 1
• □ It has been determined whether the device falls into the near patient IVD fee item
• □ The near patient IVD budget has been prepared at 30,169 CAD
• □ The review intensity has been prepared at the Class IV scale
• □ The classification conclusion has been documented in writing
• □ The applicable annual fee rate has been confirmed

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