Thailand Medical Device Post-Market Surveillance (PMS) and Adverse Event Reporting

Thailand Post-Market Surveillance (PMS) Requirements

The Thai Food and Drug Administration (TFDA) mandates a robust Post-Market Surveillance (PMS) system for all registered medical devices to ensure continued safety. This system closely aligns with the ASEAN Medical Device Directive (AMDD), particularly its criteria and timelines for adverse event reporting (Annex 5).

---

⚠️ Adverse Event (AE) Reporting

The TFDA requires the reporting of qualifying device defects and Adverse Events (AEs) that occur both inside and outside of Thailand, provided the product is currently marketed in the country.

Reportable Events

An incident qualifies as reportable if:

• The medical device is suspected to be a contributory cause of the incident.
• The incident led to death, a serious deterioration in the state of health, or serious threat to public health.
• New information indicates the device could lead to, or has previously led to, a serious event.

Reporting Timelines

Adverse Events must be reported to the TFDA immediately and not later than the following maximum timeframes:

Incident Type	Maximum Reporting Timeline
Serious Threat to Public Health	48 hours
Death or Serious Injury	10 days
Recurrence Could Lead to Death/Serious Harm	30 days

Reports can be submitted via hard copy, email, or through the Medical Device Problem Reporting System (online portal).

🛠️ Field Safety Corrective Actions (FSCA)

A Field Safety Corrective Action (FSCA) is required when the product owner must take action (including device recall) to eliminate or reduce the risk of identified hazards.

• This action applies only to a device that has already been distributed in the market.
• The product owner, manufacturer, importer, and/or authorized distributor in Thailand are responsible for performing and completing the FSCA within the Member State.

---

📚 Record Keeping and Responsibilities

The local License Holder (Registrant) plays a critical role in PMS, including:

• Complaint Records: Maintaining records of all complaint reports, subsequent investigations, analyses, and corrective actions taken.
• Traceability: Keeping proper and appropriate importation and/or distribution records to ensure traceability of devices on the market.
• Retention Period: All records of devices sold in Thailand must be kept for no less than 5 years for TFDA inspection.
• Annual Report: Registration Holders are also required to submit an annual report to the TFDA.