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.
The section 'Principal action = pharmacological/biolog' is incomplete. Complete it with: 'Principal action = pharmacological/biological → regulated as a pharmaceutical drug by DGDA. In case of genuine uncertainty about principal action (e.g., medicated wound dressings with both mechanical and chemical action), request a formal DGDA determination in writing before filing.'