On January 30, 2025, the Thai Food and Drug Administration (Thai FDA) announced new guidelines regarding the change notification process for In Vitro Diagnostic (IVD) medical devices.
1. Addition of Medical Device Items:
The application of change for the addition of medical device items is categorized into one of the following four cases:
Case 1). Addition of Medical Device Items
- When adding reagent and testing equipment to the list under IVD cluster principles (excluding accessories).
Case 2). Addition of Medical Device Items with the Same Design
- When re-packaging already registered products to add a new production model, without changing the primary packaging.
- Addition of packaging size.
- Adding items within permissible variants under the family grouping principle.
Case 3). Addition of Medical Device Items or Software that do not Affect Performance Characteristics and Product Specifications.
- Adding a product model that improves usability (ergonomic)
- Adding a new software version.
Case 4). Addition of Accessories to Main Medical Devices
- Addition of Class I accessories (e.g., diluent tubes) already mentioned in the original medical device documentation.
For change notifications corresponding to the four cases above, the following common documents must be submitted.
- Labeling
- IFU
- DoC
- LoA
- Adverse Event (AE) or Field Safety Corrective Action (FSCA) or Executive Summary
- Marketing History
- Documents providing the reason for product addition
2. Reduction of Medical Device Items:
The documents to be submitted for the change notification of reducing medical device items are as follows:
- Importer’s explanation letter (mandatory submission, for example, in cases of item reduction due to Adverse Events (AE) or Field Safety Corrective Actions (FSCA))
Please refer to the list of required documents for each case when applying for the addition or change of medical device items.
Please refer to the attached document below.
If you have any questions about medical device,
please contact us with the below.
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