Classification Overview
DGDA · GHTF-based · Class A · B · C · D
Risk-Based Classification System
Bangladesh uses a GHTF-derived four-class risk classification system. Classification determines whether registration is mandatory and what documentation is required.
Risk Classes at a Glance
| Class | Risk Level | Registration Required | ISO 13485 | Examples |
|---|---|---|---|---|
| A | Low | ❌ Not required | Not required | Tongue depressors, bandages, non-sterile gauze, examination gloves (non-sterile), wooden spatulas |
| B | Low-moderate | ✅ Mandatory (5 yr) | ✅ Required | Hypodermic needles, suction equipment, blood pressure cuffs, non-implantable patient monitoring devices |
| C | Moderate-high | ✅ Mandatory (5 yr) | ✅ Required | Lung ventilators, infusion pumps, bone fixation plates, dialysis equipment |
| D | High | ✅ Mandatory (5 yr) | ✅ Required | Heart valves, implantable defibrillators, total joint replacements, coronary stents |
Classification Rules (GHTF-Based)
Classification is determined using Annexure 1 of the DGDA Registration Guidelines, which applies GHTF principles based on:
1. Invasiveness
- Non-invasive — does not penetrate the skin or body → generally lower class
- Invasive into orifice — enters natural body openings → moderate class
- Invasive into body cavity (surgically or otherwise) → higher class
- Implantable — fully absorbed/placed inside the body → Class D (high risk)
2. Duration of Contact
| Duration | Definition | Risk Impact |
|---|---|---|
| Transient | < 60 minutes | Lower |
| Short-term | 60 min–30 days | Moderate |
| Long-term | >30 days | Higher |
3. Active vs Non-Active
- Active devices depend on an energy source (electrical, hydraulic, pneumatic). Active devices used to diagnose, monitor, or treat critical conditions carry higher risk.
- Non-active devices rely on gravity or the body's own energy.
4. Intended Purpose
The manufacturer's stated intended purpose is primary. Classification follows the riskiest intended use where multiple uses apply.
5. Anatomical Location
Devices in contact with the central nervous system, cardiovascular system, or used in blood transfusion carry higher risk.
Multiple Rules — Highest Class Applies
If a device falls under multiple classification rules simultaneously, the highest resulting class applies.
Classification Process
- Define the intended purpose as stated by the manufacturer — this is the starting point
- Apply Annexure 1 rules from the DGDA Registration Guidelines
- Identify all applicable rules — a device may trigger multiple rules
- Assign the highest class indicated by any applicable rule
- Document the classification rationale — this must be included in the registration dossier
DGDA guidance supports a conservative approach. If a device could fall in Class B or C under different interpretations, classify as Class C. The rationale:
- Registering a higher-class device as lower class = compliance violation and enforcement risk
- Registering a lower-class device as higher class = wasted registration resources but no regulatory risk
Document your classification rationale clearly in the dossier to support the classification chosen.
IVD Classification
IVD devices follow separate classification rules within the same A–D framework, based on:
- User type — professional laboratory use vs lay/self-testing
- Clinical impact — consequence of an incorrect test result for individual patient
- Public health significance — whether an incorrect result could have population-level consequences (e.g., blood screening)
| IVD Class | Typical Examples |
|---|---|
| A | General lab instruments (centrifuges, pipettes), culture media, general staining reagents |
| B | Pregnancy tests, blood glucose self-test meters, urine test strips |
| C | HIV confirmatory tests, hepatitis B surface antigen, PSA tests, rubella IgG |
| D | Blood donor screening for HIV, hepatitis C, West Nile virus, syphilis |
Special Cases
- Combination products: Classified based on the principal action component. If uncertain, seek DGDA determination.
- Software: Classified within A–D framework based on clinical function and risk of the software's output. See Software & IVD Classification.
- Accessories: Classified independently based on their own risk profile, not necessarily the same class as the device they accompany.
- Systems and procedure packs: May be eligible for grouped registration. See Guidance & Resources for grouping rules.
Accessories: Classified independently based on their own risk profile. If an accessory is critical to a device's essential function, it may be classified in the same class as the principal device or higher, depending on the risk assessment.
Example: A sterile introducer sheath for a Class D catheter may itself be classified as Class C or D if its failure could compromise the device's safety.