Post-Market Surveillance Plan

Thai FDA · MDCD · Class 3–4 mandatory · ASEAN AMDD

Overview

License holders for all registered devices must maintain an ongoing post-market surveillance (PMS) system. For Class 3 and 4 devices, a formal PMS plan is required as part of the registration dossier (CSDT Section 11), and MDCD may require Periodic Safety Update Reports (PSURs).

PMS Plan Contents

A compliant PMS plan must address:

Element	Description
Complaint collection	System for receiving complaints from Thai users, distributors, and healthcare facilities
Complaint evaluation	Decision tree — does the complaint constitute a reportable adverse event?
Adverse event monitoring	Review of data from Thai users, international vigilance databases, and scientific literature
Literature surveillance	Periodic review of published literature for safety signals
International FSCA tracking	Monitoring FSCAs in other markets for the same device
CAPA system	Process for implementing and verifying corrective and preventive actions
Periodic review	Regular internal review of accumulated PMS data
Risk management feedback	Mechanism to update risk management file based on PMS findings

Complaint Handling in Thailand

All product complaints from Thailand 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 or revealing a systemic issue
4. Responded to — CAPA where a systemic issue is identified
5. Reported to MDCD if the complaint is a reportable adverse event

Maintain Thai-language (or bilingual) complaint receipt capability — Thai healthcare providers should be able to report in Thai.

Periodic Safety Update Reports (PSURs)

For Class 3 and Class 4 devices, MDCD may require PSURs at defined intervals. PSURs summarise:

• All adverse events and complaints received during the period
• Summary of FSCAs initiated or in progress
• Assessment of benefit-risk balance based on accumulated PMS data
• Changes to the risk management file
• Conclusions and planned post-market actions

Confirm PSUR interval requirements with MDCD for your specific device — requirements vary by device type and risk class.

CAPA System

Step	Action
1. Problem identification	Document complaint, AE, audit finding, or PMS signal
2. Root cause analysis	Identify the underlying cause
3. Corrective action	Address the immediate problem
4. Preventive action	Address the systemic cause
5. Verification	Confirm CAPA effectiveness
6. Closure	Document with evidence

Distribution Record Requirements

Maintain traceability records from receipt to end customer:

• Customer name, address, contact
• Device model and lot/batch number
• Delivery date and quantity

Essential for recall execution and MDCD audit. See Recalls.

Risk Management Integration

PMS findings must feed into the device's ISO 14971 risk management file. If PMS reveals:

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

...then the risk management file must be updated. Significant changes that affect the benefit-risk profile or labelling require a variation application to MDCD before implementation.

Post-Market Clinical Follow-Up (PMCF) — Class 3–4

For Class 3 and 4 devices, clinical follow-up activities post-approval may be required:

• Continued clinical monitoring through literature review and registry participation
• Post-market clinical studies where pre-market data was insufficient
• Systematic collection of real-world clinical outcome data

PMCF findings are incorporated into the periodic PMS review and PSUR.