Expedited & Concise Pathways
TH-Unique · Concise Evaluation route · 1–3 month time saving
The Concise Evaluation Route
Thai FDA provides a Concise Evaluation (Reliance) Route for devices that already hold approval from a recognised reference regulatory authority. This pathway:
- Accepts the reference NRA's technical evaluation as the basis for Thai FDA assessment
- Reduces the documentation burden
- Saves approximately 1–3 months compared to the standard review timeline
- Is available for Class 2, 3, and 4 devices (not just Class 1)
Reference NRA Approvals Accepted
Thai FDA accepts approvals from the following reference regulatory authorities for the Concise route:
| Authority | Jurisdiction |
|---|---|
| FDA (CDRH/CBER) | United States (510(k)/PMA/De Novo) |
| EU Notified Body | European Union (CE marking) |
| TGA | Australia |
| Health Canada | Canada |
| PMDA | Japan |
| MHRA | United Kingdom |
| HSA | Singapore |
| ASEAN NRAs | ASEAN member states in some cases |
Confirm the current list of accepted reference authorities with the MDCD before planning your submission, as the list may be updated.
Eligibility Requirements
To use the Concise route:
- Device holds a current, valid approval from a recognised reference NRA
- The device submitted to Thai FDA is identical to the reference-approved device in: intended purpose · materials · specifications · design
- Technical specifications are the same as submitted to the reference NRA
- Thai FDA reserves the right to escalate to full review if safety concerns exist
Concise Route Documentation
The Concise evaluation uses a reduced CSDT dossier:
| Document | Requirement |
|---|---|
| Evidence of reference NRA approval | Current approval letter/certificate |
| Identical device declaration | Written declaration from manufacturer |
| Abbreviated device description | Confirming identity with reference submission |
| Thai FDA-specific documents | Thai labelling, AR/Establishment License details |
| ISO 13485 certificate | Required |
| Risk management summary | Abbreviated version acceptable |
Clinical Evidence for Concise Route
For the Concise route, Thai FDA accepts the reference NRA's clinical assessment as the primary clinical evidence base. The applicant does not need to repeat the full clinical evaluation, but must:
- Confirm the device is identical to what was evaluated by the reference NRA
- Provide performance data relevant to Thai patient population if the device category warrants it
- Explain any differences between the reference market and Thailand context
Time Savings
| Route | Class 2–3 Notification | Class 4 License |
|---|---|---|
| Standard | 2–4 months | 4–8+ months |
| Concise | 1–3 months | 3–5 months |
| Time saved | ~1–3 months | ~1–3 months |
Recommendation
If your device holds FDA clearance/approval, CE marking, TGA registration, or approval from any accepted reference authority, the Concise route is the recommended first-choice approach for Thailand. The documentation reduction and time saving are significant, and the device profile already meets international standards.