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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

On October 3, 2024, the Thai FDA announced updates to the consent form used for the Reliance Program. In the updated version, it is no longer necessary to include the reference number for the application submission to the Thai Food and Drug Administration. Applicants can now prepare the consent form and submit it along with

Last September 30, 2024, the Thai FDA Facebook page shared an infographic on how to classify wound dressing products according to the Thai Medical Device Act B.E. 2551 (2008), as amended by the Medical Device Act (No. 2) B.E. 2562 (2019). Related stakeholders shall consider the criteria when determining whether or not wound dressing products can

On October 2, 2024, the Thai FDA published an infographic on its official website about the Renewal, Termination, and Non-Renewal of five (5) Thai FDA Licenses applicable for local importers and manufacturers. The steps to be taken are as follows: Download the forms from the Medical Device Control Division’s website. Register for an OPEN ID

On September 9, 2024, TFDA released an amendment of Ministry of Public Health Notification, RE: Medical Devices that Must Display Expiration Dates, Warnings, Contraindications, or Precautions on Labels or Instruction For Use B.E. 2563 (2020), dated on April 27, 2020. By virtue of the provisions in Section 5 paragraph one, and Section 6 (13), and

On September 9, 2024, TFDA released an amendment of the “Ministry of Public Health Notification, RE: Medical Devices to be Sold Only to Health Care Unit or Medical Practitioner and Public Health Professionals B.E. 2563 (2020) dated on April 27, 2020”. By virtue of the provisions under Section 5 paragraph one and Section 6 (10)

On September 9, 2024, TFDA released an amendment of the “Ministry of Public Health Notification, RE: Standards of Medical Devices that Manufacturers or Importers Must Comply With, B.E. 2563 (2020), dated on April 27, 2020”. By virtue of the provisions in Section 5, paragraph one, and Section 6 (4) of the Medical Device Act B.E.

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

To ensure that the control measure of medical devices is appropriate to the current situation and in line with the development of medical technology, it is expedient to cancel the announcements from the Ministry of Public Health related to medical devices for the detection of SARS-CoV-2 (COVID-19). Therefore, the Minister of Public Health, upon recommendation

The Thai Food and Drug Administration Office (TFDA) has adjusted control measures for the diagnostic test kits and related reagents for SARS-CoV-2 (COVID-19) detection to align with the risk levels of medical devices. The previous requirements for technology assessment and related standards for manufacturers or importers of COVID-19 test kits have been canceled. Nowadays COVID-19

The Thai Food and Drug Administration (FDA) issued an infographic regarding the guideline for registration of notified medical device for diagnostic test kits and reagents for SARS-CoV-2 (COVID-19). The infographic (in Thai) can be accessed here. The main idea of this infographic is referred from the Ministry of Public Health Notification RE: Cancellation of Ministry

Medical Device Control Division would like to inform entrepreneurs to follow the guidelines for displaying warnings, prohibitions, and precautions in advertising medical devices in accordance with the Thai FDA announcement. The criteria, methods and conditions for issuing licenses and medical device advertising license 2021 (B.E. 2564), with details according to the manual for requesting permission

On  August 27, 2024, Thailand FDA published an infographic about Medical Device Advertisement on their official Facebook page.  Here are some examples of “text, images, or advertising” that are “not allowed” in advertising medical devices: Using words or statements about the benefits, quality, quantity, standards, ingredients, or origin of medical devices in an exaggerated manner,

On August 20, 2024, Thailand FDA published an infographic about the registration of diagnostic tests for Monkeypox (Mpox) in Thailand. The information shared is as follows: ● Monkeypox Diagnostic Test is categorized as  Medical devices for in vitro diagnostics (IVD) group and classified as Notify medical devices (Class B or C portal). ● Documents for

Last July 24, 2024, Thailand FDA released an infographic about Advertisement of Medical Devices Direct to Health Professionals. The summary of the information is as follows: Advertising medical devices that are exempt from authorization to healthcare professionals is a form of direct advertising with specific characteristics and methods aimed only at healthcare and public health