On January 30, 2025, the Thai Food and Drug Administration (Thai FDA) issued new Change Notification Guidelines for Notified and Licensed In Vitro Diagnostic (IVD) Medical Devices. These guidelines outline updated regulatory requirements and take effect from January 15, 2025.
The full announcement is available on the Thai FDA Official Website (กองควบคุมเครื่องมือแพทย์) [in Thai].
The full announcement is available on the Thai FDA Official Website (กองควบคุมเครื่องมือแพทย์) [in Thai].
Key Updates
1. Addition of Medical Device Items
Manufacturers and importers submitting change requests for adding medical device items must categorize their application into one of the following four cases:
Case 1: Addition of Medical Device Items
- Adding new reagents or analyzers under the IVD cluster grouping principle (excluding accessories).
Case 2: Addition of Medical Device Items with the Same Design
Examples:
- Adding new product models resulting from repackaging of previously registered products, with no change in primary packaging.
- Introducing new package sizes.
- Adding variants within the scope of Permissible Family Grouping Variants.
Case 3: Addition of Medical Device Items or Software with No Impact on Performance or Product Specification
Examples:
- Adding product models with ergonomic improvements.
- Updating to new software versions.
Case 4: Addition of Accessories for the Main Medical Device
Examples:
- Adding Class 1 accessories (e.g., Diluent Tube) that were already listed in the original Instruction for Use (IFU).
2. Reduction of Medical Device Items
- An explanation letter from the importer detailing the reason for the reduction (mandatory).
- If the reduction is due to Adverse Events (AE) or Field Safety Corrective Actions (FSCA), applicants must also provide:
- A Declaration Letter from the manufacturer.
- AE/FSCA reports justifying the product removal.
Appendix 1: Required Documents When Applying to Add Medical Devices Based on Each Case
A List of Required Documents for Change Notification Effective from January 15, 2025, for Listing Medical Devices (Class 1)
| No. | Required Documents | Case 1 | Case 2 | Case 3 | Case 4 |
|---|---|---|---|---|---|
| 1 | Device Labelling (according to the announcement on labels and IFU, updated version) | ✓ | ✓ | ✓ | ✓ |
| 2 | Instruction for Use (according to the announcement on labels and IFU, updated version) | ✓ | ✓ | ✓ | ✓ |
| 3 | Declaration of conformity (updated version) | ✓ | ✓ | ✓ | ✓ |
| 4 | Letter of authorization (updated version, for importers only) | ✓ | ✓ | ✓ | ✓ |
| 5 | Comparison table of design, specification, intended use/indication between existing registered products and newly added products | ± | ✓ | ✓ | ± |
| 6 | Device description | ✓ | ± | ± | ✓ |
| 7 | Adverse event (AE)/Field safety corrective action (FSCA) or Executive summary (updated version) | ✓ | ✓ | ✓ | ✓ |
| 8 | Manufacturing Information | ✓ | ± | ± | ✓ |
| 9 | Marketing history with copies of licenses or registration approval evidences from regulatory agencies recognized by Thai FDA, or Executive summary (updated version) | ✓ | ✓ | ✓ | ✓ |
| 10 | Summary Verification & validation (updated version) | ✓ | ± | ± | ± |
| 11 | ISO/GMP Quality Management System Certification (Proof of quality management system) | ± | ± | ± | ± |
| 12 | Document explaining reasons for product addition | ✓ | ✓ | ✓ | ✓ |
| 13 | Clinical Evidence (updated version) | ✓ | ± | ± | ± |
| 14 | Cybersecurity documentation | ± | ± | ± | ± |
| 15 | Risk analysis (updated version) | ✓ | ± | ± | ± |
| 16 | Evidence of change approval from the regulatory agency | ± | ± | ± | ± |
Legend:
✓ refers to Mandatory
± refers to Must be attached if the change notification affects the above documents. If not affect, please attach the IVD-F-09 form “Declaration Letter for Required Document Attachments with No Significant Changes from Original Product License
✓ refers to Mandatory
± refers to Must be attached if the change notification affects the above documents. If not affect, please attach the IVD-F-09 form “Declaration Letter for Required Document Attachments with No Significant Changes from Original Product License
