Recalls & Field Safety Corrective Actions

Thai FDA · MDCD · Medical Device Act B.E. 2562

When a Recall Is Required

A recall (a type of FSCA involving physical return of devices) is required when:

• A device in the market presents a defect or safety risk requiring its removal from use or sale
• MDCD issues a recall order based on post-market surveillance findings
• The manufacturer initiates a global recall that includes devices distributed in Thailand
• Post-market adverse event data identifies a systematic safety problem with distributed devices

MDCD Notification — Before Notifying Users

The license holder must notify MDCD before or simultaneously with notifying users and distributors. Do not begin a recall without first alerting MDCD.

Notification to MDCD should include:

• Nature of the safety issue
• Device identification (name, model, registration number, lot/batch numbers affected)
• Scope of distribution in Thailand (number of units, recipients)
• Proposed corrective action (recall, modification, notification)
• Proposed timeline

Recall Classification

Thai FDA classifies recalls by severity:

Class	Risk Level	Description
Class I	High	Reasonable probability of serious adverse health consequence or death
Class II	Moderate	May cause adverse health consequence; probability of serious harm is remote
Class III	Low	Unlikely to cause adverse health consequence; minor defect or labelling issue

MDCD determines the classification. The class affects urgency, communication requirements, and expected timelines for completion.

Recall Process

1. Identify affected devices — lot numbers, models, distribution scope in Thailand
2. Notify MDCD with recall details
3. Prepare Field Safety Notice (FSN) — Thai language (or bilingual) — clearly describing the issue, affected devices, and required action
4. Distribute FSN to all known users (hospitals, clinics, distributors) who received affected devices
5. Collect devices — coordinate logistics for device return or on-site destruction where applicable
6. Track and reconcile — record each device's disposition (returned, destroyed, confirmed as unused, not located)
7. Interim reports to MDCD during recall execution if requested
8. Final report to MDCD — complete reconciliation of affected units and outcomes

Distribution Records for Recall Execution

Effective recall execution depends on being able to identify and contact all recipients. License holders must maintain distribution records sufficient to trace each device or lot to the point of delivery:

• Customer name and contact (hospital, clinic, distributor)
• Device model and lot/batch number
• Date and quantity supplied

Without adequate distribution records, a complete recall is impossible and MDCD may take enforcement action.

MDCD-Ordered Recalls

MDCD may order a mandatory recall if:

• The license holder fails to initiate a voluntary recall when required
• A device presents an imminent and serious risk to public health
• Post-market data indicates a safety problem requiring urgent action

Failure to comply with an MDCD recall order is a serious violation of the Medical Device Act B.E. 2562.

International Recalls — Scope Assessment

When a recall is initiated in another market:

1. Identify whether affected lot numbers were distributed in Thailand
2. If yes — initiate Thai FSCA/recall process immediately
3. If no — document the scope assessment and retain for MDCD inspection
4. Notify MDCD of significant international recalls even where no Thai action is required

Record-Keeping

Maintain the following for every recall:

• Initial MDCD notification record (with date and timestamp)
• Field Safety Notice (approved version, distribution list)
• Confirmation of FSN receipt from customers
• Device disposition records (units returned, destroyed, confirmed unused)
• Final recall completion report

Retain records for the expected device lifetime or as directed by MDCD.