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. This list is periodically updated; confirm the current list with MDCD before planning your submission:

Authority	Jurisdiction
FDA (CDRH/CBER)	United States (510(k)/PMA/De Novo)
EU Notified Body	European Union (CE marking)
TGA	Australia
Health Verify 'Verify 'Health Canada' reference — the content should specify whether this refers to Health Canada's Medical Devices Directorate (MDD) or Biologic and Radiopharmaceutical Drugs Directorate (BRDD) approval, or if it is actually recognized by Thai FDA. If unsure, flag with MDCD.' reference — the content should specify whether this refers to Canada's Medical Devices Directorate (MDD) or Biologic and Radiopharmaceutical Drugs Directorate (BRDD) approval, or if it is actually recognized by Thai FDA. If unsure, flag with MDCD.	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:

1. Device holds a current, valid approval from a recognised reference NRA
2. The device submitted to Thai FDA is identical to the reference-approved device in: intended purpose · materials · specifications · design
3. Technical specifications are the same as submitted to the reference NRA
4. 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.

Correct the reference NRA entry to read clearly:

Authority | Jurisdiction Health Canada (Medical Devices Directorate / Biologic and Radiopharmaceutical Drugs Directorate) | Canada

Alternatively, if Health Canada is NOT recognized by Thai FDA, remove this entry and add a note: 'Confirm the current list of accepted reference authorities with the MDCD before planning your submission, as the list may be updated.'