The respective announcement became effective since September 20^th, 2024. These processes eliminate the need for specialist evaluation, significantly reducing time and costs for businesses. This article provides an in-depth look at these new processes and their requirements.

Understanding the Thai FDA Definitions

• Refer: This process allows referencing an approved dossier to submit a new application when changing the medical device's name (Change of Brand Name).
• Transfer: This process facilitates the transfer of an approved dossier due to a change in the registered establishment (License Transfer).
• Original Dossier: The dossier of an approved medical device that is complete without referencing documents from other dossiers.

 

Refer Process: Change in the Brand Name

The Refer process enables companies to register a new brand name for an existing medical device by referencing a previously approved dossier. The following conditions shall be applied:

1. The referred dossier must be an original dossier.
2. The original dossier must be a Full CSDT, approved via Full Evaluation.
3. As for importation, the medical devices must be manufactured by the same manufacturer under the same product owner. For domestic manufacturing, the devices must be manufactured at the same registered establishment.
4. The establishment license of the importer and the approval certificate of the referenced registration must be active and not expired, revoked, or suspended.

 

Transfer Process: Change in License Holders

The Transfer process is applicable when there is a change in the registered license holder, such as changing from Importer A to Importer B. The following condition shall be applied:

1. The registration dossiers to be transferred must be Full CSDT dossiers. In cases where the original dossier was registered in Partial format, a supplementary dossier must be attached to comply with Full CSDT.
2. As for importation, the medical devices must be manufactured by the same manufacturer under the same product owner. For domestic manufacturing, the address of the manufacturer must remain the same.
3. The approval certificate of the transferred registration must be active and not expired, revoked, or suspended.

 

Comparison of Required Documents:

The following is a side-by-side comparison of the key documentation required for both processes, as announced on October 2024:

Required Documents	Refer	Transfer
Label, Instructions for Use	Amendment required due to the change in the medical device's name.	Amendment may be required due to changes in the license holder.
Executive Summary		Use the same version as the transferred dossier.
Declaration of Conformity		Amendment required due to changes in the license holder.
Letter of Authorization (for importer)		Amendment required due to changes in the license holder.
Same Dossier as Referenced/Transferred	Required (must be the same version of the dossier being referenced, with certification letter that the documents are identical).	Required (must be the same version of the dossier being transferred, with certification letter that the documents are identical).
Declaration Letter of Identicality	Declaration of Identicality for Refer of Medical Device Registration Dossier (Thai FDA template).	Declaration of Identicality for Transfer of Medical Device Registration Dossier (Thai FDA template).
Letter of Consent	Letter of Consent for Refer of Medical Device Registration Dossier Template (Thai FDA template).	Letter of Consent for Transfer of Medical Device Registration Dossier (Thai FDA template).
Safety Declaration Letter	Required	Required
E-Submission	Attach the above three letters under "Other Attachments 1" and indicate the Refer request in the remarks section.	Attach the above three letters under "Other Attachments 1" and indicate the Transfer request in the remarks section.
Additional Actions	Not applicable	Original dossier registration will be canceled; the license holder must submit license withdrawal documents within 30 days.

 

Guidelines Exclusions

These guidelines do not apply in the following cases:

1. If the medical device has a history of serious adverse events or deficiencies that could lead to significant adverse effects.
2. If there are concerns regarding the quality, efficacy, or safety of the medical device.
3. The Refer process does not permit the referencing of methamphetamine test kits for urine.

 

Important Considerations

It is important to note that the Thai FDA has not yet provided detailed guidance on the limitations, timeframes, or fees associated with these processes.

 

Conclusion

By allowing brand name changes and license transfers, Thai FDA is streamlining regulatory pathways for manufacturers and importers. However, businesses must strictly adhere to the conditions outlined by the authority to ensure compliance. Companies should remain vigilant for future updates to ensure full adherence to all regulatory requirements.

 

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References:

• Thai FDA Announcement: Guidelines for Referencing Existing Documents, Document Transfer, and Other Cases in Submitting Applications for Manufacturing and Importing Licensed and Notified Medical Devices Without Specialist Evaluation Requirements by Government Agencies or Organizations Designated by the Thai Food and Drug Administration B.E. 2567 (2024)
• Transfer Process Announced on October 4, 2024
• Refer Process Announced on October 4, 2024