Thailand Post‑Market Requirements for Medical Devices and IVDs

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.

• Maintaining manufacturing, import and distribution records and submitting the reports applicable to the establishment. Check the current notification, retention period, reporting year and due date instead of applying an older annual-report instruction without review.

• 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. An FSCA has a separate reporting track from the adverse event: assess the initial 48-hour and follow-up 21-day requirements in the applicable Thai notification and current submission instructions. Record implementation and reporting dates.

Renewals, changes and the reporting calendar

Track each establishment and product authorization separately using its actual expiry and renewal conditions. Do not assume that every authorization can be renewed automatically by paying a fee or that an unchanged dossier requires no review. Reconcile manufacturer details, models, labeling, QMS and any pending changes before renewal.

Use Thai FDA's current postmarket and legal materials for the applicable manufacturing/import/sales records and reporting rules, including newer 2025/2026 measures. Keep routine periodic reports separate from urgent incidents and field safety actions. An annual deadline never postpones a serious safety report.

Maintain a responsibility matrix linking the manufacturer, Thai holder, importer and distributors. Record awareness dates, reportability decisions, local stock and customers, corrective action, follow-up and effectiveness checks. Compare proposed product changes with the authorized dossier and labeling requirements before releasing a new configuration.