Software & IVD Classification
DGDA · Drug and Cosmetics Act 2023 · Software as "Drug" · BD-Unique
Software as a Medical Device — BD-Unique
The 2023 Act's Landmark Change
The Drug and Cosmetics Act, 2023 explicitly includes software in its definition of a medical device. Critically, medical device software is categorised as a "Drug" in Bangladesh's regulatory taxonomy — bringing it squarely under the DGDA's authority and mandatory registration requirements.
This classification has no parallel in most other markets and has direct practical consequences:
- Registration is mandatory for Class B/C/D software products
- ISO 13485 QMS certification is required (covering software development)
- Software lifecycle documentation (IEC 62304) is expected as part of the technical dossier
- The AR holds the registration — software developers must appoint a Bangladesh-based AR
What Counts as Medical Device Software?
| Software Type | Medical Device? | Typical Class |
|---|---|---|
| AI diagnostic tool analysing medical images | ✅ Yes | C or D |
| Drug dosing decision support system | ✅ Yes | C |
| Patient monitoring app that alerts clinicians | ✅ Yes | B or C |
| ECG analysis software | ✅ Yes | B or C |
| Software controlling a Class D active implant | ✅ Yes | D (accessory) |
| Administrative EMR/HIS without clinical decisions | ❌ No | — |
| General wellness/fitness tracker | ❌ No | — |
| Telemedicine video call platform only | ❌ No | — |
Software Classification Principles
Software is classified using the standard Class A–D rules applied to:
- The severity of the health condition the software is intended to address
- The significance of the software's output or recommendation to clinical decisions
- Whether the software drives a clinical action or merely provides general information
High-severity condition + software output directly drives treatment = Class C or D Low-severity condition + software provides background information = Class A or B
Documentation for Software Registration
| Document | Requirement |
|---|---|
| Software description and intended use | Required |
| IEC 62304 software lifecycle documentation | Expected for Class B/C/D |
| IEC 62366-1 usability engineering | Expected |
| ISO 14971 risk management (software hazards) | Required |
| Algorithm validation evidence (AI/ML) | Required where applicable |
| Cybersecurity risk assessment | Expected |
| ISO 13485 certificate covering software development | Required for Class B/C/D |
IVD Classification
In vitro diagnostic devices use the same Class A–D system with separate rules applying GHTF IVD classification principles.
IVD Classification Factors
1. Individual Risk — the consequence to the individual patient if the test result is incorrect:
- Does a wrong result lead to inappropriate treatment or missed diagnosis?
2. Public Health Risk — could incorrect results have population-level consequences?
- Blood screening tests where a false negative could contaminate the blood supply are Class D
3. User Expertise — self-test (lay user) devices are classified higher than professional-use devices with equivalent technology
IVD Class Descriptions
Class A IVD — Low individual and public health risk
- General laboratory instruments, culture media, sample collection tubes
- No registration required
Class B IVD — Moderate individual risk, low public health risk
- Self-testing devices: blood glucose meters, pregnancy tests, home urine analysis
- Professional general-purpose diagnostic kits
Class C IVD — High individual risk or moderate public health risk
- Tests for HIV, hepatitis B/C, rubella, PSA, tumour markers
- HLA typing, drugs-of-abuse testing
Class D IVD — High risk to both individuals and public health
- Blood/organ donation screening: HIV, Hep B/C, West Nile virus, syphilis
- Confirmatory tests for legally significant conditions
Combination Products
Products combining a medical device with a pharmaceutical component are classified based on the principal intended action:
- Principal action = device mechanism → regulated as a medical device by DGDA
- Principal action = pharmacological/biological mechanism → may be regulated as a pharmaceutical drug
If the boundary is unclear, seek a formal DGDA classification determination before proceeding.
Accessories
An accessory to a medical device is classified in its own right. The accessory's class is based on its own risk profile and intended use, not the class of the parent device.