Regulatory Affairs Update: Thailand

Thailand: FDA Infographic Announced the Process Involving Approved Licenses (Refer and Transfer)

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).

ConditionsLicense Process
ReferTransfer
Original dossierMust 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.
ImportsBoth 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 manufacturersBoth 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 deviceActiveActive
Cases where transfer is not allowedReferTransfer
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:

  1. Submit the application for approval or detailed notification in Full CSDT format, for either Refer or Transfer application.
  2. Attach the required documents as follows:
List of DocumentsReferTransfer
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 devicechanges 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 systemSpecify that the application is referencing previous dossiers from the license or notification numberSpecify 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).

Should you have any inquiries or require further assistance, please do not hesitate to contact us at sales@andamanmed.com or click the button below.

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