Post-Market Surveillance for Medical Devices in Thailand
Post‑market surveillance is the ongoing process of collecting, recording, and analyzing data about medical device performance and safety once the device is in use. In Thailand, medical device PMS requirements include:
- Reporting any device defects or adverse events (AEs), whether they occur inside or outside Thailand, if the device likely contributed to the incident.
- Keeping records of devices you manufacture, import, or sell for at least five years. For expired devices, records should be kept for at least one year beyond the expiration date. Annual reports must be submitted before March 31 each year.
- Ensuring all device labeling complies with Thai regulations and guidance.
- Maintaining compliance with advertising regulations and obtaining Thai FDA approval and supporting evidence for all advertising claims.
The Thai FDA’s Medical Device Control Division (MDCD) also conducts regular inspections of manufacturing sites in Thailand and collects device samples from the market for testing. If devices fail to meet the quality, safety, or performance standards outlined in the original registration dossier, the TFDA can enforce a mandatory recall. The results of inspections or testing are made public, and you may be asked to remove unsafe products from the market.
Medical Device Vigilance Reporting Requirements in Thailand
Vigilance reporting is the formal process of notifying Thai FDA when a medical device incident occurs that meets reporting criteria. Establishment License Holders and Product License Holders must report any device defects or adverse events (AEs) occurring either domestically or abroad if the device is suspected to have contributed to the incident. Failure to submit timely vigilance reports can result in regulatory penalties, suspension of your license, or product recalls.
You must submit a report if an event:
- Caused or could have caused death or serious injury
- Required medical intervention to prevent serious harm
- Involved a malfunction that could recur and cause harm
The Thai FDA provides specific reporting forms for domestic and foreign incidents as well as for field safety corrective actions (FSCA). AE reports are submitted through the Medical Device Problem Reporting System on the Health Product Vigilance Centre website. Reporting timelines for domestic AEs depend on event severity:
- Immediately or within 48 hours: Serious threat to public health
- Immediately or within 10 days: Death or serious injury
- Within 30 days: Risk of death or serious injury if the event recurs
A follow-up report is required within 30 days of the initial submission. Reports must be submitted twice a year for events that occurred outside Thailand. When an FSCA is triggered, such as recall, modification, or safety notification, the initial FSCA report must be filed within 48 hours of implementation, with a follow-up sent within 21 days.
License Renewals for medical devices in Thailand
Medical device licenses must be renewed every five years. Renewal applications are submitted through the SKYNET e-submission system between October 1 and December 31. The documentation required for renewal depends on how your device was originally registered.
Group 1: Medical devices registered under full CSDT
If your device was registered with a full Common Submission Dossier Template (CSDT) under the current rules, renewal is automatic upon payment. No additional documents are required unless you are renewing an HIV-related test kit, in which case you must include a product analysis report.
Group 2: Medical devices registered under Partial 1 or Partial 2
Additional supporting documentation is required along with Adverse Event Reports from the past five (5) years.
