Borderline & Combination Products
Borderline products
A borderline product is a product that could potentially be regulated as either a medical device or another product category (drug, natural health product, cosmetic). Common borderline situations include:
Borderline with drugs
- An antiseptic spray: is it a drug or a device?
- A contraceptive gel: drug or device?
- A wound dressing impregnated with an antimicrobial agent: device or drug?
Borderline with cosmetics
- A tooth-whitening product: cosmetic or device?
- An anti-wrinkle light therapy device: device or cosmetic?
- A laser hair removal device: device (radiation emitting) or cosmetic?
Borderline with natural health products
- A herbal wound cream: NHP or device?
Borderline with wellness products
- A fitness tracker with heart rate monitoring: medical device or consumer product?
- A stress management app with biofeedback: SaMD or wellness app?
How Health Canada handles borderline cases
Health Canada determines product category based on:
- Intended purpose — what the manufacturer claims the product does
- Primary mode of action — how the product achieves its effect
- Product composition — for drug-device combinations
Manufacturers uncertain about product category can request a product classification determination from Health Canada prior to beginning the regulatory process.
Combination products (drug-device)
A combination product is a product that combines a medical device and a drug (or biologic) in a single integral product. Health Canada determines regulatory pathway based on the primary mode of action:
| Primary mode of action | Regulated as | Lead regulator |
|---|---|---|
| Drug/biologic | Drug or biologic | Pharmaceutical regulatory pathway |
| Device | Medical device | Device Licence pathway |
Examples
| Product | Primary mode of action | Regulated as |
|---|---|---|
| Drug-eluting stent | Device (scaffold) | Medical device |
| Pre-filled syringe (with drug) | Drug | Drug (device component reviewed as part of drug submission) |
| Antibiotic wound dressing | Drug (antibiotic) | Drug |
| Insulin pen (without drug) | Device | Medical device |
| Antimicrobial catheter | Device | Medical device (with attention to drug component) |
Seeking clarification
For novel or genuinely ambiguous products, Health Canada offers:
- Product classification consultations — informal guidance on product category
- Pre-Submission Meetings — for cases where regulatory pathway is uncertain
Early engagement is strongly recommended for combination products and borderline cases, as late-stage classification determinations can have significant consequences for a product's development timeline.
Legislative source: Food and Drugs Act, s 2 (definitions of "device" and "drug"); Medical Devices Regulations, SOR/98-282, s 2