What is a Medical Device?
The statutory definition
A medical device is defined in the Health Products Act (Cap. 122D) as any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related article that:
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is intended by the manufacturer to be used, whether alone or in combination, for human beings for one or more of the following specific purposes:
- diagnosis, prevention, monitoring, treatment, or alleviation of disease;
- diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or disability;
- investigation, replacement, modification, or support of the anatomy or of a physiological process;
- supporting or sustaining life;
- control of conception;
- disinfection of medical devices; or
- providing information by means of in vitro examination of specimens derived from the human body;
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and does not achieve its principal intended action by pharmacological, immunological, or metabolic means — though it may be assisted in its function by such means.
The full definition appears in section 2 of the Health Products Act and is replicated in regulation 2 of the Health Products (Medical Devices) Regulations 2010.
The intended purpose test
The most important element of the definition is intended purpose — what the manufacturer states the device is for, as expressed in:
- the label and labelling;
- instructions for use (IFU);
- promotional materials; and
- other statements made by the manufacturer.
This means that the same physical product may or may not be a medical device depending on how the manufacturer presents and markets it. A light source used for phototherapy is a medical device; an identical light source sold as ambient lighting is not.
HSA provides an online "Is it a medical device?" tool at the SHARE portal to help manufacturers and importers determine whether their product falls within scope.
Common examples by category
| Category | Examples |
|---|---|
| Diagnostic equipment | Blood glucose monitors, ECG machines, diagnostic ultrasound |
| Implants | Pacemakers, orthopaedic implants, intraocular lenses, stents |
| In vitro diagnostics (IVDs) | HIV test kits, pregnancy test kits, COVID-19 antigen tests |
| Surgical instruments | Scalpels, forceps, electrosurgical units |
| Software | Clinical decision support software, AI-assisted diagnostic software classified as SaMD |
| Consumables | Catheters, syringes, wound dressings, surgical gloves |
| Monitoring devices | Pulse oximeters, continuous glucose monitors, infusion pumps |
What is not a medical device
Products explicitly excluded from the definition, or which typically fall outside scope, include:
- Therapeutic products (medicines, biologics) that achieve their principal action pharmacologically, immunologically, or metabolically — these are regulated under a separate Part of the Health Products Act;
- Cosmetic products used solely for aesthetic purposes with no medical claim;
- Health supplements and traditional medicines;
- General-purpose laboratory equipment not intended for use with human-derived specimens for diagnostic purposes;
- Personal protective equipment (PPE) not carrying a medical intended purpose (though surgical masks with medical claims are within scope).
See What is Not a Medical Device for a fuller treatment of boundary cases.
Borderline and combination products
Some products sit on the boundary between medical devices and other regulated product categories:
- Device–drug combinations (e.g. a drug-eluting stent or an antibiotic-coated catheter): where a drug plays a secondary role to the device's primary function, the product is regulated as a Class D medical device. Where the drug is primary, it is regulated as a therapeutic product.
- Device–cosmetic borderlines (e.g. whitening dental trays, skin fillers): depends on whether the intended purpose includes a medical claim.
- Software and digital health products: software that meets the intended purpose test is regulated as a medical device (SaMD). HSA has published specific guidance on the SaMD classification pathway — see Digital Health and SaMD.
For borderline cases, HSA's Consultation Schemes and the Innovation Office offer pre-submission advisory services.