Post-Market Surveillance Plan

DGDA · GHTF PMS principles · CAPA · AR obligations

Overview

Holders of DGDA registrations (ARs) must maintain an active post-market surveillance (PMS) system for the life of the registration. PMS is not a one-time dossier submission — it is an ongoing programme that collects and evaluates device performance data and feeds findings back into risk management and regulatory obligations.

PMS Plan Contents

A PMS plan should address:

Element	Description
Complaint collection	System for receiving complaints from users, distributors, and healthcare facilities in Bangladesh
Complaint evaluation	Criteria for determining whether a complaint constitutes a reportable adverse event
Adverse event monitoring	Review of data from users, international vigilance databases, and scientific literature
Literature surveillance	Periodic review of published literature for safety signals relating to the device
International FSCA monitoring	Tracking FSCAs issued in other markets for the same device
CAPA system	Process for implementing and verifying corrective and preventive actions
Periodic PMS review	Regular internal review of accumulated PMS data
Risk management update	Mechanism to update the risk management file based on PMS findings

Complaint Handling

All product complaints from Bangladesh users must be:

1. Received and logged in a complaint register
2. Evaluated — does the complaint meet the adverse event reporting threshold?
3. Investigated — root cause analysis for events meeting the threshold
4. Responded to — corrective action where a systemic issue is identified
5. Reported to DGDA — if the complaint is a reportable adverse event (see Adverse Event Reporting)

Maintain records of all complaints and their resolution. DGDA inspectors will review complaint handling records.

CAPA System

The CAPA (Corrective and Preventive Action) system is central to effective PMS:

Step	Action
1. Problem identification	Document the issue — complaint, AE, internal audit finding, or PMS signal
2. Root cause analysis	Investigate the underlying cause
3. Corrective action	Address the immediate problem
4. Preventive action	Address the systemic cause to prevent recurrence
5. Effectiveness verification	Confirm the CAPA worked — follow-up monitoring
6. Closure	Document closure with evidence of effectiveness

Distribution Records

Distribution records must enable full traceability of any device or lot from receipt to end customer. Maintain records of:

• Date of receipt and lot/batch numbers
• Quantity received per lot
• Customer name, address, and contact (hospital, clinic, distributor)
• Date and quantity delivered per customer
• Device model and DGDA registration number

These records are essential for recall execution and are inspected by DGDA during market surveillance visits.

Periodic PMS Review

Conduct a periodic review of all PMS data — at minimum annually. The review should cover:

• Complaint frequency and trends
• All adverse events reported to DGDA
• Open and closed CAPA status
• Any FSCAs in other markets for this device
• International regulatory actions or safety notices
• Updates to the scientific literature

Document the review and retain records. If the review identifies new safety signals, update the risk management file and assess whether a variation application to DGDA is required.

PMS and Risk Management Integration

PMS findings must be fed back into the device's risk management file (ISO 14971). If PMS reveals:

• A new hazard not previously identified
• Higher frequency of a known adverse event than predicted
• An ineffective risk control

...then the risk management file must be updated. If the update changes the benefit-risk conclusion or requires a label change, a variation application to DGDA is likely required before implementation.

Record Retention

Retain all PMS records (complaint logs, AE reports, CAPA records, distribution records, periodic review reports) for:

• The duration of the DGDA registration validity, plus
• A reasonable period beyond — generally the expected lifetime of the device, or as directed by DGDA in any specific guidance