Thailand Medical Device Registration (TFDA Overview)
1. Regulatory Authority & Legal Framework
Thailand regulates medical devices under:
- Medical Device Act B.E. 2551 (2008)
- Ministerial Regulations (2018–2022 reforms)
- TFDA Notifications on risk classification, labeling, CSDT dossier requirements
Regulatory authority:
Thai FDA (TFDA) – Medical Device Control Division.
Submission platform: Thai FDA e-submission system (E-sub / Full Submission Portal).
2. Device Classification (A/B/C/D – Risk-Based, ASEAN/GHTF-Aligned)
| Class | Risk Level | Registration Route |
|---|---|---|
| Class 1 | Low | Listing |
| Class 2 | Low–Moderate | Notified Registration |
| Class 3 | Moderate–High | Notified / Licensed Registration |
| Class 4 | High | Licensed Registration |
Thailand often refers to the ASEAN Medical Device Directive (AMDD) for classification.
Examples:
- Class 1: Surgical gloves, bandages
- Class 2: Suction pumps, infusion equipment
- Class 3: Blood glucose meters, HF surgical units
- Class 4: Ventilators, implantables, surgical robots
3. Registration Routes
3.1 Listing (Class 1 Devices)
- Simplified submission
- Basic administrative documentation
- Technical summary
- Approval time: 1–2 months
3.2 Notified Registration (Class 2 & some Class 3 Devices)
- Requires CSDT dossier
- Verification of safety & performance
- Manufacturer QMS (ISO13485)
- Faster than Licensed route
- Approval time: 3–6 months
3.3 Licensed Registration (High-Risk Class 3 & Class 4 Devices)
Required for:
- Implantable devices
- High-risk active devices (ventilators, infusion pumps)
- Surgical robots / AR systems
- Life-support systems
Includes:
- Full CSDT dossier
- Clinical evidence / CER
- TFDA technical review
- Approval time: 6–9+ months
4. Dossier Format (ASEAN CSDT)
Thailand follows the ASEAN Common Submission Dossier Template, including:
Administrative Documents
- Application form
- Power of Attorney
- Letter of Authorization for Local Authorized Representative (LAR)
- FSC or Market Authorization from reference countries
- ISO 13485 of manufacturer
- Declaration of Conformity
Technical Documents
- Device description & intended purpose
- Design verification & validation
- Biocompatibility
- Electrical safety (IEC 60601 series)
- Software documentation (IEC 62304)
- Sterilization validation (if applicable)
- Risk analysis (ISO 14971)
- Clinical evaluation (CER)
- Labeling & IFU (Thai requirements)
5. Local Authorized Representative (LAR)
Foreign manufacturers must appoint a Thai In-Country Representative, responsible for:
- Product registration
- Licenses & import permits
- Post-market surveillance (vigilance)
- Recall & corrective actions
- Advertising approvals
TFDA allows multiple importers, but each needs permission from the LAR.
6. Official Fees (Typical)
TFDA fees vary by risk class:
- Class 1 (Listing): THB 1,000–3,000
- Class 2 (Notified): THB 5,000–10,000
- Class 3 (Notified/Licensed): THB 10,000–20,000
- Class 4 (Licensed): THB 20,000–30,000
Additional fees may apply for:
- Labeling approval
- Import license
- Annual establishment license renewal
7. Timelines
- Class 1 Listing: 1–2 months
- Class 2 Notified: 3–6 months
- Class 3 Licensed: 6–9 months
- Class 4 Licensed: 9–12+ months (depends on clinical evidence quality)
Fast-track options may apply if the device already has CE/FDA/TGA/Health Canada approvals.
8. Labeling Requirements
Labeling must comply with TFDA rules, including:
- Thai language labeling (mandatory for end-user information)
- Device name/model
- Manufacturer & LAR details
- Country of origin
- Lot/Serial number
- Manufacturing & expiry date (if applicable)
- Storage/handling instructions
- IFU (Thai or bilingual EN + Thai summary)
9. Import & Post-Market Requirements
Import Process
- Importer establishment license
- Online import permit application
- Customs clearance with HS code alignment
Post-Market Surveillance
- AE/incident reporting
- Field safety corrective actions (FSCA)
- Record keeping & traceability
- Advertising approval (mandatory for Class 3/4 & claims-based marketing)
10. Notes for Your Device Portfolio (Consulting View)
| Device Type | Typical Class | Thailand Requirements |
|---|---|---|
| Soft contact lenses | Class 3 | CER required, biocompatibility mandatory |
| Surgical robots / SyngAR™ AR/MR guidance | Class 4 | Full Licensed Registration, strong software & cyber documentation |
| High-frequency electrosurgical equipment | Class 3/4 | EMC + electrical safety + usability; strong verification data |
| Blood glucose meters & strips | Class 3 | Must meet ISO 15197 performance data |
| Serum preparation device (single-use) | Class 2/3 | Depends on invasiveness + sterile validation |
11. Key Advantages of the Thailand Market
- ASEAN CSDT alignment makes dossier harmonization easy across SEA
- Predictable timelines
- Fast-track available for internationally approved devices
- Growing private hospital market with high import demand