Regulatory Strategy & Product Classification (Canada)

Classification is the first regulatory decision because it determines the licensing route, submission depth, quality-system expectations and the level of evidence Health Canada will review.

Define Your Health Canada Pathway

How NKB Approaches Classification

We begin with the device definition and intended use rather than selecting a class based on a superficially similar product. We assess the regulatory characteristics that drive classification and document the rationale so the downstream licensing strategy is built on a defensible basis.

Confirm whether the product meets the Canadian definition of a medical device or IVD.

Review intended use, indications, target population and user environment.

Apply the non-IVD or IVD classification rules under Schedule 1 of the Medical Devices Regulations.

Assess invasiveness, duration of contact, active functions, energy transfer, monitoring functions and consequences of device failure for non-IVDs.

For IVDs, assess the analyte, intended purpose, testing context, donor/transfusion implications, disease significance and consequences of an incorrect result.

Determine Class I, II, III or IV and the resulting MDL/MDEL/MDSAP route.

Identify applicable standards, labelling requirements and evidence expectations.

Non-IVD Classification Drivers (Schedule 1 Part 1)

Degree of invasiveness (non-invasive, invasive via body orifice, surgically invasive)
Duration of contact (transient <60 min, short term up to 30 days, long term >30 days)
Active functions and energy delivery (thermal, electrical, ionizing radiation)
Monitoring of vital physiological parameters and automated diagnostic feedback
Biological impact, central circulatory system contact, central nervous system contact
Consequences of device failure or malfunction on patient safety

IVD Classification Drivers (Schedule 1 Part 2)

Analyte detected and biological/clinical significance
Intended purpose (screening, diagnosis, monitoring, prognosis, staging)
Testing context: laboratory professional vs. Point-of-Care (PoC) / Near-patient vs. Self-testing
Public health implications (blood donor screening, critical infectious diseases)
Consequences of false positive or false negative results on patient management

Expert Focus:

The question is not simply “What class is this device?” It is “What regulatory obligations are triggered by this classification, and what evidence will Health Canada expect for this risk profile?”

Determine Your Health Canada Risk Classification

Our Canadian regulatory specialists establish the formal classification rationale and map your pathway to market.

Book a Consultation