On October 4, 2024, Thai FDA released an announcement in their website about processes involving approved license. The Thai FDA defines the following:
Refer: For the process that requires referring the approved dossier of medical devices to new dossiers with changes new name for the medical device (Change of Brand Name).
Transfer: For the process that requires transferring the approved dossier of medical devices due to a change in the registered establishment (License Transfer).
Conditions | License Process | |
---|---|---|
Refer | Transfer | |
Original dossier | Must be registered in the Full CSDT route. | - Must be registered in the Full CSDT route. |
- In case the original dossier was registered in partial route, it is required to submit all documents in accordance with Full CSDT. | ||
Imports | Both medical devices (from the original and new dossiers) must be produced by the same manufacturer and under the same product owner. | The name and address of the manufacturer and product owner must remain unchanged. |
Local manufacturers | Both medical devices must be registered by the same manufacturing establishment. | The manufacturing location must remain the same. |
Status of the establishment and the license or notification of the original medical device | Active | Active |
Cases where transfer is not allowed | Refer | Transfer |
---|---|---|
If there is a history of problems or serious incidents. | ✓ | ✓ |
If there are concerns about the quality, efficacy, or safety. | ✓ | ✓ |
For methamphetamine test kits in urine, the guidelines from the TFDA announcement on quality standards for these kits B.E.2559 (2016) must be followed. | ✓ | N/A |
Process:
- Submit the application for approval or detailed notification in Full CSDT format, for either Refer or Transfer application.
- Attach the required documents as follows:
List of Documents | Refer | Transfer |
---|---|---|
1. Device Labelling | ✓ | ✓ |
2. IFU | ✓ | ✓ |
3. EXECUTIVE SUMMARY | ✓ | ✓ |
4. Declaration of conformity | ✓ | ✓ |
5. Letter of authorization (for importer only) | changes in the name of the medical device | changes in the registered establishment. |
6. Other documents as required by ministerial regulations | ✓ | ✓ |
The same documents as those from the original dossiers being referred to or transferred must be attached, with a confirmation letter that they are the same documents | ||
7. Additional requirement: | ✓ | ✓ |
7.1 Declaration of Identicality for Refer/Transfer of Medical Device Registration Dossier | ||
7.2 Letter of Consent for Refer/Transfer of Medical Device Registration Dossier Template | ||
7.3 Safety Declaration | ||
The files should be consolidated and attached under "Other Attachments 1" in the E-submission system. | ||
In the "Remarks" section of the application within the E-submission system | Specify that the application is referencing previous dossiers from the license or notification number | Specify that the application is transferring previous dossiers from the license or notification number |
The new processes is effective starting September 20, 2024.
For more information refer to กองควบคุมเครื่องมือแพทย์ (moph.go.th).
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