Three Approval Pathways
TH-Unique · Listing · Notification · License · 5-year validity for all
Overview
Thailand's Medical Device Act B.E. 2562 establishes three distinct approval pathways based on device risk class:
| Pathway | Class | Review Level | Approximate Timeline |
|---|---|---|---|
| Listing | Class 1 (Positive List only) | Automatic / administrative | Days to weeks |
| Notification | Class 2 and 3 | Moderate technical review | Weeks to months |
| License | Class 4 | Full technical review | Several months |
5-Year Validity: All three approval types expire after 5 years and must be renewed.
Pathway 1 — Listing (Class 1)
The Listing pathway is available only for Class 1 devices that appear on the Thai FDA's Positive List. It is the fastest and least burdensome pathway.
Requirements
- Device appears on the Positive List
- Basic product information submitted to Thai FDA
- Minimal technical documentation (device description, intended use, basic labelling)
- Establishment License held by the manufacturer or importer
Process
- Confirm device is on the current Positive List
- Submit listing form via Thai FDA e-submission system
- Thai FDA confirms listing
- Device may be commercially distributed
Important: Class 1 devices not on the Positive List cannot use the Listing pathway and must proceed via Notification.
Pathway 2 — Notification (Class 2 and 3)
The Notification pathway applies to Class 2 and 3 devices. This is the most commonly used pathway in volume terms, covering the broad middle range of the market.
Requirements
- Full CSDT dossier (see CSDT & Documentation)
- ISO 13485 QMS certificate
- Risk management documentation (ISO 14971)
- Clinical / performance evaluation evidence
- Thai FDA-compliant labelling
Process
- Prepare CSDT dossier
- Submit via Thai FDA e-submission portal
- Thai FDA administrative review (completeness check)
- Thai FDA technical review
- Notification issued — device may be commercially distributed
Typical timeline: Weeks to months; varies with device complexity and Thai FDA workload.
Pathway 3 — License (Class 4)
The License pathway applies to Class 4 (high-risk) devices. This is the most rigorous pathway with the most comprehensive dossier requirements and longest review timeline.
Requirements
- Comprehensive CSDT Full format dossier
- Complete clinical evidence — often including clinical investigations
- Full risk management documentation
- Manufacturing site information and GMP evidence
- Advisory panel review may occur for novel or first-of-kind devices
Process
- Prepare comprehensive CSDT dossier
- Submit via e-submission system
- Thai FDA administrative review
- Technical review — may involve advisory input for complex devices
- License issued — device may be commercially distributed
Typical timeline: Several months.
Pathway Selection Guide
| Your Device | Pathway |
|---|---|
| Class 1 + on Positive List | Listing |
| Class 1 + not on Positive List | Notification |
| Class 2 | Notification |
| Class 3 | Notification |
| Class 4 | License |
5-Year Validity and Renewal
All Thai FDA approvals (Listing, Notification, License) expire after 5 years. Renewal must be completed before expiry:
- Submit renewal application well before the expiry date
- Provide updated ISO 13485 certificate
- Declare any changes to the device during the 5-year period
- MDCD reviews and issues renewed approval for a further 5 years
A lapsed approval means the device cannot legally be distributed — track expiry dates carefully.