The Medical Device Control Division has introduced an updated Change Notification System for medical devices in Thailand, effective January 15, 2025. The newly issued guideline regulates the increase or decrease of medical device items within the same medical device group without affecting their category classification.
This guideline has been published under the authority of the Thai Food and Drug Administration (Thai FDA) and specifies documentation requirements based on the classification of medical devices. Appendix 1 and Appendix 2 outline the required documents for each classification.
This guideline has been published under the authority of the Thai Food and Drug Administration (Thai FDA) and specifies documentation requirements based on the classification of medical devices. Appendix 1 and Appendix 2 outline the required documents for each classification.
Key Updates in the Change Notification System
Changes for Class 1 Medical Devices
- Modification to Increase and Decrease Medical Device Items
- Purpose: Adjust the number of medical device items within the same application while allowing changes in category grouping.
- Type: Jor Jor Nor 3 and Jor Jor Por 3
- Required Documents: 10 documents (See Appendix 1)
- Modification to Increase Medical Device Items
- Purpose: Add medical device items within the same application while allowing changes in category grouping.
- Type: Jor Jor Nor 3 and Jor Jor Por 3
- Required Documents: 10 documents (See Appendix 1)
- Modification to Decrease Medical Device Items
- Purpose: Remove medical device items within the same application while allowing changes in category grouping.
- Type: Jor Jor Nor 3 and Jor Jor Por 3
- Required Documents: 1 document (See Appendix 1)
- Changes to Import or Manufacturing Location Information on Label and IFU
- Purpose: Update import location (for imports) or manufacturing location (for domestic production) on the label and Instructions for Use (IFU).
- Type: Jor Jor Nor 4 and Jor Jor Por 4
- Required Documents: 1 document (See Appendix 1)
Changes for Class 2–4 Medical Devices
- Modification to Increase Medical Device Items
- Purpose: Add medical device items within the same application while allowing changes in category grouping.
- Type: Major change
- Required Documents: 16 documents (See Appendix 2)
- Modification to Decrease Medical Device Items
- Purpose: Remove medical device items within the same application while allowing changes in category grouping.
- Type: Minor change
- Required Documents: 1 document (See Appendix 2)
- Changes to Import or Manufacturing Location Information on Label and IFU
- Purpose: Update import location (for imports) or manufacturing location (for domestic production) on the label and IFU.
- Type: Minor change
- Required Documents: 1 document (See Appendix 2)
Additional Conditions for Change Notifications
- Newly added medical device items must comply with the original registration pathway. For example, if the initial registration was approved through the Abridge evaluation pathway, all newly added items must undergo the same Abridge evaluation process, including submission of corresponding supporting documents.
- If certain documents were not required in the initial registration, they are not required in the change notification. Instead, an explanation letter must be provided.
Further Information
For more details, visit the Thai FDA Official Website (in Thai): กองควบคุมเครื่องมือแพทย์ (moph.go.th)
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Appendices
Appendix 1
A List of Required Documents for Change Notification Effective from January 15, 2025, for Listing Medical Devices (Class 1)
| No. | List of Required Documents | Change Topic | |||
|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | ||
| 1 | Device Labelling according to the announcement on labeling and documentation requirements for medical devices (updated version) | / | / | ||
| 2 | Instruction for Use (IFU) according to the announcement on labeling and documentation requirements for medical devices (updated version) | / | / | ||
| 3 | Product specification | / | / | ||
| 4 | Device Description and features | / | / | ||
| 5 | Materials | / | / | ||
| 6 | Declaration of conformity (updated version) | / | / | ||
| 7 | Letter of authorization (updated version) for importers | * | * | ||
| 8 | Sterilization test report in case of sterilized medical devices | * | * | ||
| 9 | Documentation showing testing or verification in case of medical devices with Measuring function | * | * | ||
| 10 | Documentation showing the results of standard testing according to the announcement, in case where medical devices require specific requirements | * | * | ||
| 11 | Notification letter from importer with reasons | / | |||
| 12 | Notification letter for changes to import location information (for imports) or manufacturing location information (for domestic production) on device labeling and IFU | / | |||
Legend:
/ refers to Required document
* refers to Require in case of the involved products
Appendix 2
A List of Required Documents for Change Notification Effective from January 15, 2025 for Notified and Licensed Medical Devices (Class 2-4)
| No. | List of Required Documents | Change Topic | ||
|---|---|---|---|---|
| 1 | 2 | 3 | ||
| 1 | Device Labelling according to the announcement on labeling and documentation requirements for medical devices (updated version) | / | ||
| 2 | Instruction for Use (IFU) according to the announcement on labeling and documentation requirements for medical devices (updated version) | / | ||
| 3 | Declaration of conformity (updated version) | / | ||
| 4 | Letter of authorization (updated version) for importers | * | ||
| 5 | Comparative table of design, specification, intended use/indication between existing and new products | / | ||
| 6 | Device description | / | ||
| 7 | Adverse event (AE)/ Field safety corrective action (FSCA) | / | ||
| 8 | Manufacturing Information | / | ||
| 9 | Marketing history with attached approval certificate or license from other countries recognized by Thai FDA | / | ||
| 10 | Summary Verification & validation (updated version) | / | ||
| 11 | ISO/GMP Quality System Certificate | / | ||
| 12 | Explanation Letter outlining the justifications for the addition of the product | / | ||
| 13 | Clinical Evidence (updated version) | * | ||
| 14 | Cybersecurity documentation | * | ||
| 15 | Risk analysis documentation (updated version) | * | ||
| 16 | Evidence of receiving approval for changes from the authority that approves the product | * | ||
| 17 | Notification letter from importer with reasons | / | ||
| 18 | Notification letter for changes to import location information (for imports) or manufacturing location information (for domestic production) on device labeling and IFU | / | ||
Legend:
/ refers to Required document
* refers to Require in case of the involved products
