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Vigilance & Adverse Event Reporting

Thai FDA · MDCD · Medical Device Act B.E. 2562 · ASEAN AMDD vigilance

What Must Be Reported​

The license holder must report to Thai FDA/MDCD any adverse event where a registered device:

  • Caused or contributed to death of a patient, user, or other person
  • Caused or contributed to serious injury — hospitalisation, medical/surgical intervention required, permanent impairment, or life-threatening situation
  • Malfunctioned in a way that, if it recurred, could cause or contribute to death or serious injury
  • Presents a risk of serious public health concern

Borderline cases (uncertain whether the event meets the threshold) should be reported — over-reporting is preferable to missing a mandatory report. MDCD will advise on whether a full investigation is required.

Reporting Timeframes​

Event TypeTimeframe
Death or serious injuryWithin 10 calendar days of the license holder becoming aware
Public health emergencyImmediately
Reportable malfunction (recurrence risk)Within 30 calendar days
Summary / trend reportsAs requested by MDCD

The 10-day and 30-day clocks start from when the license holder (not the manufacturer) becomes aware. Establish clear procedures for distributors and users in Thailand to report events to the license holder promptly.

How to Report​

Adverse event reports are submitted to Thai FDA/MDCD using the designated reporting form and channel. Confirm current submission process with MDCD (contact: mdcd@fda.moph.go.th or fda.moph.go.th). Reports should include:

  • Device identification (product name, model, lot/batch number, CSDT registration number)
  • Event description (what happened, when, where, patient/user outcome)
  • Initial assessment of whether the device caused or contributed to the event
  • Corrective actions taken or planned

Preliminary reports must be submitted within the applicable timeframe even if the investigation is incomplete. A final report follows once the investigation is concluded.

License Holder Obligations​

  1. Establish a complaint and adverse event intake procedure accessible to Thai users and distributors
  2. Evaluate all complaints to determine whether they constitute reportable adverse events
  3. Investigate in coordination with the manufacturer — obtain root cause analysis
  4. Submit preliminary and final reports to MDCD
  5. Maintain complete event records — investigation, CAPA, correspondence with MDCD

Field Safety Corrective Actions (FSCAs)​

An FSCA is required when a device presents an unacceptable risk that was not previously identified or has become newly significant.

FSCA Types​

TypeDescription
RecallPhysical return of affected devices
Device modificationOn-site correction or upgrade
RelabellingCorrection of safety-critical label or IFU
User notificationSafety advisory without device return
Market withdrawalRemoval from sale for non-safety reasons (not an FSCA)

FSCA Process​

  1. License holder identifies safety issue
  2. Notify MDCD before or simultaneously with notifying users — do not send FSN to users before MDCD is aware
  3. Prepare a Field Safety Notice (FSN) in Thai (for Thai healthcare providers) or bilingual Thai/English
  4. Distribute FSN to all known users and distributors of affected devices in Thailand
  5. Coordinate with MDCD on any border interception needed (for devices in transit)
  6. Track FSN receipt and corrective action compliance
  7. Submit FSCA completion report to MDCD with reconciliation records

FSN Content​

The FSN must clearly state:

  • Description of the safety issue
  • Device identification (name, models, lot numbers affected)
  • Risk presented and clinical implications
  • Action required from the user or healthcare facility
  • Contact information for the license holder

The license holder must monitor for trends in complaints or adverse events that, even if individual events do not meet the reporting threshold, together indicate a systemic safety issue. Trend reporting to MDCD may be required when a pattern of events suggests an elevated rate above expected background.

International FSCAs​

If the manufacturer initiates an FSCA in another market for the same device, assess whether the FSCA is applicable in Thailand:

  • If affected lot numbers are distributed in Thailand, initiate the Thailand FSCA process
  • If affected products have not been distributed in Thailand, document the assessment and file it
  • Notify MDCD of significant international FSCAs even if Thailand-specific action is not required