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

1. Define the intended purpose as stated by the manufacturer — this is the starting point
2. Apply Annexure 1 rules from the DGDA Registration Guidelines
3. Identify all applicable rules — a device may trigger multiple rules
4. Assign the highest class indicated by any applicable rule
5. Document the classification rationale — this must be included in the registration dossier

When in doubt, classify higher

DGDA guidance supports a conservative approach. If a device could fall in Class B or C under different interpretations, classify as Class C. Registering a lower-class device as a higher class wastes resources; registering a higher-class device as lower class is a compliance violation.

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.