On February 10, 2025, the Thai Food and Drug Administration (FDA) released updated guidelines for submitting change notifications related to the addition or reduction of medical device items for non-in-vitro diagnostic (non-IVD) medical devices. These guidelines outline the required documentation for various types of change requests and took effect on January 15, 2025.
Key Highlights
1. Addition of Medical Device Items
Change requests for adding medical device items are categorized into four cases:
Case 1: Addition of Medical Device Items
- Example: Adding a foam dressing for diabetic wounds under the single medical device grouping, where the added item differs in size from the originally registered item.
Case 2: Addition of Medical Device Items with the Same Design
Examples include:
- Repackaging a registered product while maintaining the same primary packaging.
- Introducing a new pack size within the existing packaging.
- Adding items that vary under permissible variants based on the family grouping principle.
Case 3: Addition of Medical Device Items or Software Without Impacting Performance
Examples include:
- Adding new product models with enhanced ergonomics.
- Introducing new software versions.
Case 4: Addition of Accessories for the Main Medical Device
- Example: Adding accessories already referenced in the original Instructions for Use (IFU) from the initial application.
Document Requirements for Adding Medical Device Items
The table below outlines the required documents for each case:
| 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 affected, please attach “Non-IVD_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 affected, please attach “Non-IVD_Declaration Letter for Required Document Attachments with No Significant Changes from Original Product License”
2. Reduction of Medical Device Items
When submitting a change notification to reduce medical device items, the following documentation is required:
- An explanation letter from the importer detailing the reason for the reduction.
- If the reduction is due to an Adverse Event (AE) or Field Safety Corrective Action (FSCA), a declaration letter from the manufacturer must be submitted. This letter should include AE/FSCA reports outlining the cause of the reduction.
Next Steps
For more information, visit the official website: กองควบคุมเครื่องมือแพทย์ (Thai FDA Official Website in Thai).
If you have any questions or require assistance with your application, contact us at sales@andamanmed.com or click the button below.
If you have any questions or require assistance with your application, contact us at sales@andamanmed.com or click the button below.
