What Is a Medical Device?
DGDA · Drug and Cosmetics Act, 2023 · GHTF-aligned definition
Statutory Definition
Under Bangladesh's Drug and Cosmetics Act, 2023, a medical device is defined as any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related article — whether used alone or in combination — that is intended by the manufacturer to be used in or on human beings for:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease
- Diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap
- Investigation, replacement or modification of anatomy or a physiological process
- Control of conception
The principal intended action must not be achieved by pharmacological, immunological, or metabolic means — that distinction separates medical devices from medicines.
Software as a Medical Device — BD-Unique
A landmark change introduced by the Drug and Cosmetics Act, 2023 is the explicit inclusion of software within the medical device definition. Critically, medical device software is categorised under the "Drugs" regulatory category in Bangladesh, which brings it within DGDA's jurisdiction.
This has significant implications for:
- Health app developers whose software provides diagnostic or therapeutic functions
- Hospital information systems with clinical decision support functions
- AI/ML tools used in clinical diagnosis or treatment planning
- Remote monitoring software connected to physical medical devices
What counts as medical device software?
| Category | Medical Device? |
|---|---|
| Software that diagnoses disease from patient data | ✅ Yes |
| Software that monitors vital signs and alerts clinicians | ✅ Yes |
| Software controlling an active medical device | ✅ Yes |
| Administrative/billing/scheduling software | ❌ No |
| General wellness apps without medical claims | ❌ No |
| Electronic health record storage only | ❌ No |
What Is an IVD?
An in vitro diagnostic (IVD) medical device is a reagent, instrument, apparatus, or software intended for examination of specimens derived from the human body to provide information about physiological or pathological states, congenital anomalies, or safety and compatibility of potential recipients.
IVDs are classified within the same Class A–D framework as general medical devices, using separate classification rules that take into account user expertise (professional vs. lay use) and the clinical impact of incorrect test results.
What Is Not a Medical Device?
The following are generally not regulated as medical devices under DGDA:
- Pharmaceutical drugs — products whose principal action is pharmacological, immunological, or metabolic
- Cosmetics — products applied to the body for aesthetic purposes without medical claims
- General consumer goods — items with no medical intended purpose stated by the manufacturer
- Research tools — laboratory instruments used solely for scientific research with no clinical claim
Borderline products: Products sitting at the device-drug boundary are assessed on a case-by-case basis. If uncertain, consult the DGDA for a classification determination before proceeding with registration.
Accessories
Accessories intended specifically to be used with a particular medical device to enable or assist its use are regulated as medical devices in their own right and may require separate classification and registration.
Once you confirm your product is a medical device, determine its risk class. See Classification Overview.