Adverse Event Reporting & Recalls

DGDA · Post-market vigilance · AR obligations

What Must Be Reported to DGDA

The AR must report to the DGDA any adverse event involving a DGDA-registered device where the device:

• Caused or contributed to death or serious injury to a patient, user, or other person
• Malfunctioned in a way that, if recurrence occurred, could cause or contribute to death or serious injury
• Poses a risk of serious public health concern

Report potentially reportable events (where you are uncertain whether the event meets the threshold) to the DGDA for guidance — it is better to over-report than to miss a mandatory report.

Reporting Timeframes

Bangladesh follows GHTF-aligned vigilance timeframes:

Event Severity	Reporting Timeframe
Events involving death or serious injury, or serious public health risk	As soon as possible — within 10 calendar days of the AR becoming aware
Other reportable events (malfunction with recurrence risk)	Within 30 calendar days of the AR becoming aware
Summary/trend reports	As requested by DGDA

Reporting Process

1. Become aware of event — through user complaint, clinical report, or other notification
2. Investigate — the AR coordinates with the manufacturer to investigate the event
3. File preliminary report — submit to DGDA within the applicable timeframe (even if investigation is incomplete)
4. Complete investigation — conduct full root cause analysis
5. File final report — submit to DGDA with investigation findings, root cause, and corrective actions taken
6. DGDA review — DGDA may request additional information or initiate its own investigation

How to Report

Reports are submitted to the DGDA through the contact channels specified by the DGDA (contact information and current forms available from the DGDA official website). Confirm the current submission format and channel with the DGDA as procedures may evolve.

Field Safety Corrective Actions (FSCAs)

An FSCA is required when the manufacturer (or AR in Bangladesh) identifies that a device already distributed and in use presents an unacceptable risk that was not previously identified or has become newly significant.

Types of FSCA

Type	Description
Device recall	Return of affected devices to manufacturer or AR
Device modification	On-site modification or upgrade to remedy the safety issue
Destroy/discard	Disposal of affected devices that cannot be remediated
Relabelling	Correction of safety-critical labelling errors
User notification	Safety information sent to users without device return

FSCA Process in Bangladesh

1. Manufacturer/AR identifies safety issue requiring corrective action
2. AR notifies DGDA before or simultaneously with notifying users
3. AR prepares a Field Safety Notice (FSN) — written communication to healthcare facilities describing:
   • The nature of the safety problem
   • The risk presented
   • The action required by the user
4. AR distributes FSN to all known users/distributors of affected devices
5. AR maintains comprehensive records: list of affected devices, list of FSN recipients, confirmation of receipt
6. AR confirms FSCA completion to DGDA
7. DGDA may request additional reporting or conduct its own investigation

Drug Court Enforcement — BD-Unique

Violations of the Drug and Cosmetics Act 2023 — including supply of unregistered devices (Class B/C/D), falsification of registration documents, or failure to comply with recall orders — are prosecuted in Drug Courts, Bangladesh's specialised enforcement courts for pharmaceutical and medical device violations.

Penalties may include:

• Substantial financial fines
• Imprisonment of responsible individuals
• Seizure and condemnation of non-compliant devices
• Cancellation of DGDA registration and import licences

This is a uniquely robust enforcement mechanism — regulatory non-compliance in Bangladesh carries meaningful consequences.

Recalls and Market Withdrawal

When a recall is initiated (voluntarily or by DGDA order):

• AR provides distribution records to identify all affected devices in the supply chain
• AR coordinates collection from hospitals, clinics, distributors
• AR reports recall progress to DGDA at required intervals
• AR confirms completion and provides reconciliation records to DGDA