Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
May 1, 2025
Approximately 5 minutes
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.
Ask Anything
We'll follow up with you personally.
Related Articles
Approximately 5 minutes
Thailand Medical Device Registration and Approval: Compliance with Thai FDA and AMDD
Thailand's regulatory process, overseen by the Thai FDA's MDCD, follows the Medical Device Act B.E. 2562 (2019) and aligns closely with the ASEAN Medical Device Directive (AMDD). Devices are classified into four risk categories (1-4) and require one of three approval routes: Listing, Notification, or License.
Approximately 5 minutes
Thailand Medical Device Classification: Risk Categories and Thai FDA Verification
Medical devices in Thailand are classified into four risk categories (Class 1-4) based on intended use, invasiveness, and risk, closely following ASEAN MDD rules. Manufacturers can formally confirm their device classification by submitting an online application to the Thai FDA.
Approximately 5 minutes
Thailand Medical Device Grouping Rules: Simplifying Registration and Saving Costs
Thailand's new grouping guidance simplifies the registration process, allowing multiple products to be included in a single submission. Devices must share a product owner, intended purpose, and proprietary name, and can be grouped as a Single device, Family, System, Set, IVD Test Kit, or IVD Cluster, subject to specific variant rules.
Approximately 5 minutes
Thailand Medical Device Advertising Approval: Rules for DTC and HCP Communication
The Thai FDA regulates medical device advertising based on the target audience. Direct-to-Consumer (DTC) ads require prior approval, while advertisements targeted solely at Healthcare Professionals (HCPs) are generally exempt, provided they are not visible to the public. Approval licenses are valid for up to 3 years.
Approximately 5 minutes
Thailand Medical Device Local Labeling Requirements: Language, Content, and Post-Import Affixing
Thailand's labeling rules, detailed in Ministry of Public Health Notification 137, require all home-use devices to be labeled in Thai. Devices used only by physicians can use Thai or English. The importer can affix the required labeling, including essential product and manufacturer details, within 180 days of the device entering the country.
Approximately 5 minutes
The Role of the Medical Device Control Division (MDCD) within the Thailand Food and Drug Administration (TFDA)
The TFDA is the national regulatory body in Thailand, with the Medical Device Control Division (MDCD) responsible for enforcing the Medical Device Act B.E. 2562 (2019). The MDCD oversees pre-market evaluation, registration, and post-market monitoring, ensuring medical devices comply with safety and quality standards aligned with the ASEAN MDD.