Thailand Medical Device Registration and Approval
The regulatory process for medical devices in Thailand is administered by the Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (TFDA). The current framework is based on the Medical Device Act B.E. 2562 (2019) (Issue 2) and is designed to align with the regional ASEAN Medical Device Directive (AMDD).
⚙️ Risk Classification and Approval Routes
Medical devices in Thailand are classified into four risk categories (1 through 4), following the AMDD guidance:
| Risk Class | Approval Route | Max Review Time (Standard) | Submission Format | Validity |
|---|
| Class 1 (Low) | Listing | Auto-approved or 200 days | Limited Documentation | 5 Years |
| Class 2 (Low-Moderate) | Notification | 250 days | CSDT Full Format | 5 Years |
| Class 3 (Moderate-High) | Notification | 250 days | CSDT Full Format | 5 Years |
| Class 4 (High) | License | 300 days | CSDT Full Format | 5 Years |
Note: All licenses and registrations are valid for five years and require renewal.
📝 Application Requirements
All applications, except for Class 1 (Listing), require submission in the Common Submission Dossier Template (CSDT) Full format, which is a comprehensive set of documents including:
- Executive Summary
- Device Description and Intended Use
- Essential Principles of Safety and Performance and conformity evidence.
- Summary of Design Verification and Validation
- Risk Analysis
- Proof of Foreign Regulatory Approval
- Quality Management Certification (ISO 13485) is required for Class 2–4 devices.
🌐 Expedited Pathways
The Thai FDA offers two accelerated routes for market access:
- Reliance Route: Allows manufacturers to leverage existing marketing approvals issued by the Health Sciences Authority (HSA) in Singapore. This route is available for Class B, C, and D devices that meet specific documentation criteria (CSDT identical to the version submitted to the HSA).
- Expedited Review: Available for Class 2–4 novel devices approved for at least one year by one of six major reference regulatory agencies (e.g., US FDA, EU Notified Bodies, TGA, Health Canada).
Both pathways offer benefits, including exemption from Specialist Review fees and shorter processing timelines.
👤 License Holder and Foreign Manufacturers
All import licenses must be held by a locally registered, licensed company in Thailand. This entity serves as the official registrant, coordinates with the TFDA, and retains full ownership and control of the license, offering foreign manufacturers flexibility in their local distribution strategy.
Abigail
Our Class 3 sterile catheter is sold in a very small Tyvek pouch where space is extremely limited. Does the Thai FDA permit us to provide the Thai-translated Instructions for Use (IFU) via a QR Code on the primary packaging, or is a physical Thai paper insert mandatory for every single unit? Additionally, must the "Manufacturing Date" and "Expiry Date" follow a specific Thai calendar format (Buddhist Era - B.E.), or is the international YYYY-MM-DD format acceptable?