On September 20, 2024, Thai FDA released the guidelines for submitting applications to manufacture and import Licensed and Notified Medical Devices on the condition that referencing existing documents, document transfer, or other cases of medical devices that have previously been approved and not required academic documents evaluation by experts, government agencies, organizations designated by Thai Food and Drug Administration.
By virtue of Clause 2 (1) (c) of the Food and Drug Administration Announcement on criteria, methods, and conditions for evaluating academic documents, analysis, establishment inspection, or inspection in considering approval of medical devices B.E. 2567 (2024) dated on April 23, 2024, the Secretary – General of Food and Drug Administration hereby issues the following announcement:
The guideline mentions 3 conditions:
(1) Application of New Brand: When transferring of existing documents of medical devices that have been previously approved and submitting application under new brand, the following conditions apply:
a. The referenced registration must be original and complete with no cross-referencing of other registrations.
b. The referenced registration must have full document submission as specified in Clause 2 of the Ministerial Regulation on Licensing and Issuance of Licenses for Manufacturing or Importing Medical Devices B.E. 2563 (2020) or the Ministerial Regulation on Notification of Details and Issuance of Certificate of Notification for Manufacturing or Importing Medical Devices B.E. 2563 (2020), or must have undergone a full document assessment according to Clause 2 (1) of the Food and Drug Administration Announcement on Specifying Information, Documents, or Evidence Not Required to Be Submitted under the Ministerial Regulation on Licensing and Issuance of Licenses for Manufacturing or Importing Medical Devices, and Notification of Details and Issuance of Certificate of Notification for Manufacturing or Importing Medical Devices B.E. 2567 (2024).
c. A letter of consent to transfer and use the complete registration documents from the original license holder, who have existing licensed and notified approval certificate, is required.
d. A safety declaration letter from the manufacturer or product owner is required.
e. A Declaration of Identicality stating that the medical device using the new brand and the medical device of the referenced registration are identical in all aspects of intended use, indications, manufacturing process, composition, efficacy, and quality standards from the manufacturer or product owner.
f. For import, the medical devices shall be manufactured by the same manufacturer under the same product owner. For domestic manufacturing, the medical devices shall be manufactured from the same registered manufacturing establishment.
g. The manufacturing or importing establishment certificate and the license or notification certificate of the referenced registration shall be in active, not expired, revoked, or suspended.
(2) Change of Importers: When transferring with a change of registered importing establishment, such as changing from registered importing establishment A to registered importing establishment B (from Importer A to Importer B), the following conditions apply:
a. The registration dossiers to be transferred must contain full submission documents as specified in Clause 2 of the Ministerial Regulation on Licensing and Issuance of Licenses for Manufacturing or Importing Medical Devices B.E. 2563 (2020) or the Ministerial Regulation on Notification of Details and Issuance of Certificate of Notification for Manufacturing or Importing Medical Devices B.E. 2563 (2020), or must have undergone a document assessment according to the Food and Drug Administration Announcement on Specifying Information, Documents, or Evidence Not Required to Be Submitted under the Ministerial Regulation on Licensing and Issuance of Licenses for Manufacturing or Importing Medical Devices, and Notification of Details and Issuance of Certificate of Notification for Manufacturing or Importing Medical Devices B.E. 2567 (2024).
b. The registration dossiers to be transferred that have been exempted from submitting information, documents, or evidence according to the Food and Drug Administration Notification on Specifying that Applicants for Licenses to Manufacture or Import Medical Devices Are Not Required to Submit Information, Documents, or Evidence under the Ministerial Regulation on Licensing and Issuance of Licenses for Manufacturing or Importing Medical Devices B.E. 2564 (2021) or the Food and Drug Administration Announcement on Specifying that Applicants for Notification of Details for Manufacturing or Importing Medical Devices Are Not Required to Submit Information, Documents, or Evidence under the Ministerial Regulation on Notification of Details and Issuance of Certificate of Notification for Manufacturing or Importing Medical Devices B.E. 2564 (2021) as the case may be, the applicant must submit information, documents, or evidence to fulfil complete documents as specified in Clause 2 of the Ministerial Regulation on Licensing and Issuance of Licenses for Manufacturing or Importing Medical Devices B.E. 2563 (2020) or the Ministerial Regulation on Notification of Details and Issuance of Certificate of Notification for Manufacturing or Importing Medical Devices B.E. 2563 (2020) before being able to transfer the registration documents.
c. A letter of consent to transfer registration documents from the previous registered importing establishment to the new registered importing establishment is required.
d. A safety declaration letter from the manufacturer or product owner is required.
e. A Declaration of Identicality stating that the medical devices are identical in all aspects of intended use, indications, manufacturing process, composition, efficacy, and quality standards from the manufacturer or product owner.
f. The manufacturing site and product owner must remain the same.
g. The license or notification certificate of the referenced medical devices for import shall be in active, not expired, revoked, or suspended.
(3) Change of Local Manufacturers: When transferring with a change of registered manufacturing establishment, such as changing from registered manufacturing establishment A to registered manufacturing establishment B (from Manufacturer A to Manufacturer B), the following conditions apply:
a. The registration dossiers to be transferred must contain full submission documents as specified in Clause 2 of the Ministerial Regulation on Licensing and Issuance of Licenses for Manufacturing or Importing Medical Devices B.E. 2563 (2020) or the Ministerial Regulation on Notification of Details and Issuance of Certificate of Notification for Manufacturing or Importing Medical Devices B.E. 2563 (2020), or must have undergone a document assessment according to the Food and Drug Administration Announcement on Specifying Information, Documents, or Evidence Not Required to Be Submitted under the Ministerial Regulation on Licensing and Issuance of Licenses for Manufacturing or Importing Medical Devices, and Notification of Details and Issuance of Certificate of Notification for Manufacturing or Importing Medical Devices B.E. 2567 (2024).
b. The registration dossiers to be transferred that have been exempted from submitting information, documents, or evidence according to the Food and Drug Administration Notification on Specifying that Applicants for Licenses to Manufacture or Import Medical Devices Are Not Required to Submit Information, Documents, or Evidence under the Ministerial Regulation on Licensing and Issuance of Licenses for Manufacturing or Importing Medical Devices B.E. 2564 (2021) or the Food and Drug Administration Announcement on Specifying that Applicants for Notification of Details for Manufacturing or Importing Medical Devices Are Not Required to Submit Information, Documents, or Evidence under the Ministerial Regulation on Notification of Details and Issuance of Certificate of Notification for Manufacturing or Importing Medical Devices B.E. 2564 (2021) as the case may be, the applicant must submit information, documents, or evidence to fulfil complete documents as specified in Clause 2 of the Ministerial Regulation on Licensing and Issuance of Licenses for Manufacturing or Importing Medical Devices B.E. 2563 (2020) or the Ministerial Regulation on Notification of Details and Issuance of Certificate of Notification for Manufacturing or Importing Medical Devices B.E. 2563 (2020) before being able to transfer the registration documents.
c. A letter of consent to transfer registration documents from the previous registered manufacturing establishment to the new registered manufacturing establishment is required.
d. A safety declaration letter from the new manufacturer or product owner.
e. A Declaration of Identicality stating that the medical devices are identical in all aspects of intended use, indications, manufacturing process, composition, efficacy, and quality standards from the new manufacturer or product owner.
f. The manufacturing site must remain the same.
g. The license or notification certificate of the referenced medical devices for import shall be in active, not expired, revoked, or suspended.
The guidelines cannot be applied in the following cases:
(1) If the medical device has a history of serious adverse events or device deficiencies that may lead to serious adverse device effects.
(2) If there is reason to suspect the quality, efficacy, and safety of the medical device.
This guideline is effective starting September 20, 2024 as per publication in the Government Gazette: [Published in the Government Gazette, Vol. 141, Special Issue, Part 260D, page 10, dated on September 19, 2024].
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.