Borderline and Combination Devices
What is a borderline product?
A borderline product is one whose regulatory classification is not immediately clear — it may sit on the boundary between a medical device and another regulated product category (therapeutic product, health supplement, cosmetic). Classification as a medical device or another category depends on the product's primary mode of action and the manufacturer's intended purpose as stated on the label and in promotional materials.
What is a combination product?
A combination product incorporates two regulated components — most commonly a medical device and a pharmaceutical (drug), or a medical device and a biological substance. Singapore's framework classifies these products based on which component provides the principal intended action.
Device–drug combinations
Where the device is primary
If the principal intended action is achieved by the device component and the drug plays only a secondary (ancillary) role, the product is regulated as a medical device. The device class is Class D where the incorporated drug is itself a registrable therapeutic product.
Examples:
- Drug-eluting coronary stents (stent is primary; drug coating prevents restenosis in an ancillary role)
- Antibiotic-coated catheters (catheter is primary; antibiotic coating reduces infection risk in an ancillary role)
- Haemostatic patches incorporating a drug component
Where the drug is primary
If the principal intended action is pharmacological and the device component is ancillary to delivery, the product is regulated as a therapeutic product under Part 3 of the Health Products Act.
Examples:
- Pre-filled syringes where the medicinal product inside is what is being regulated
- Transdermal drug delivery patches (the drug is primary)
Device–biological substance combinations
Devices that incorporate biological materials derived from human or animal tissues raise additional classification and safety considerations. The combination is generally classified as a medical device where the biological substance acts in an ancillary role. HSA may apply additional requirements relating to the biological component.
Examples:
- Collagen-based wound dressings
- Bovine pericardium surgical patches
Software and digital health borderlines
Software is only a medical device if it meets the intended purpose test. Wellness apps, administrative software, and general communication platforms do not meet the definition. See Digital Health and SaMD for the full framework.
Cosmetic–device borderlines
The classification boundary between a cosmetic product and a medical device depends entirely on the intended purpose claim:
| Intended purpose | Classification |
|---|---|
| "Whitens teeth" (cosmetic appearance claim only) | Cosmetic product |
| "Treats tooth sensitivity" or "remineralises enamel" | Medical device |
| "Moisturises skin" | Cosmetic product |
| "Treats eczema" or "reduces inflammation" | Therapeutic product or medical device |
Getting HSA's view
For borderline cases, HSA offers formal pre-submission consultation:
- Product classification consultation: available through HSA's Consultation Schemes. Allows applicants to obtain HSA's non-binding view on classification before committing to a regulatory pathway.
- Innovation Office: for novel product types where standard rules may not clearly apply — hsa.gov.sg/medical-devices/io.
Do not proceed with a regulatory pathway based on an assumed borderline classification without seeking HSA's view where there is genuine ambiguity. An incorrect classification discovered during evaluation requires re-submission.