Regulatory Affairs Update: Thailand

Thailand: FDA Released Draft Guidelines for Referencing Existing documents, Document Transfer, or other cases in Submitting Applications for Manufacture or Import Licenses, and Notifications for Manufacture or Import of Medical devices

On July 9, Thai FDA shared the following draft guidelines regarding license transfer and brand name amendment:

The guidelines are set up for the applications that are eligible for referencing existing documents or document transfer from approval license which do not require an expert review of the documents. It covers three main scenarios:

(1) When referencing existing approved medical device documents and submitting under a new brand name (New Brand), the following conditions apply:

a) The referenced registration must be original and complete with no cross-referencing other registrations.

b) The original registration must be a full document submission or full CSDT only.

c) A letter of consent is required from the original license holder.

d) A safety declaration letter from the manufacturer or product owner is mandatory.

e) A Declaration of Identicality confirming identical aspects between the new and referenced medical devices must be provided by the manufacturer or product owner.

f) For imports, they must originate from the same Legal Manufacturer or product owner; for domestic manufacture, from the same registered establishment.

g) The manufacturing or import establishment licenses for both the new and referenced medical devices must be active and not expired, withdrawn, or suspended.

(2) When transferring documents with a change of registered import establishment (e.g., from Importer A to Importer B), the following conditions apply:

a) The original registration can be full document submissions, full CSDT, or abridged submissions.

b) Complete documents must be provided if the original submission was exempted from certain requirements (partial submission).

c) A letter of consent for document transfer to the new registered import establishment is required.

d) A safety declaration letter from the manufacturer or product owner must be provided.

e) A Declaration of Identicality confirming identical aspects of the medical device must be provided by the manufacturer or product owner.

f) The manufacturing site and product owner must remain unchanged.

g) The license or notification for import must be active and not expired, revoked, or suspended.

(3) In case of document transfer with a change of registered manufacturing establishment, for example, changing from registered manufacturing establishment A to registered manufacturing establishment B, under the following conditions: [The conditions are similar to those for import establishments, with adjustments for manufacturing]

The guidelines cannot be applied in the following cases:

(1) Cases where the medical device has a history of serious adverse events or device deficiencies that could lead to serious adverse device effects.

(2) Cases where there are reasonable suspicions about the quality, efficacy, and safety of the medical device.

For more information, refer to this link:

If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.

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