Thai FDA Updates Medical Device Advertising Rules – Jan, 2025

The Food and Drug Administration Announcement RE: Determination of Criteria, Conditions, and Requirements for Approval, Issuance of License, and License Validity for Medical Device Advertising B.E. 2568 (2025).

Thai FDA Issues New Medical Device Advertising Regulations Effective January 2025

The key particulars are outlined below.

The Thai FDA announced revisions to the regulations governing medical device advertising. This regulation aims to enhance clarity and ensure alignment with current regulatory and advertising practices on 04 December 2024.

1. The effective date is 04 January 2025 (The date following their publication in the Government Gazette which announced on 03 Jan 2025)
2. Officially Revoke of the Food and Drug Administration Announcement RE: Determination of Criteria, Conditions, and Requirements for Approval, Issuance of License, and License Validity for Medical Device Advertising B.E. 2564 (2021)
3. This announcement does not apply to advertisements of medical devices exempted from the requirement of permission under the Ministry of Public Health (MOPH) Announcement. Please refer to the regulation.
4. The request for permission to advertise medical devices should be carried out as follows:
   • Application Requirements:
     Anyone who intend to advertise medical devices must receive a license from the Food and Drug Administration. Applications for the license (Form Kor Por. 1) and medical device advertising license (Form Kor Por. 2) must follow the formats attached to this notification. Licenses are valid for a maximum of three years from the date of issuance.
   • Amendments to Advertising Details:
     In case of changes or amendments to licensed advertising details, the license holder must submit an application to revise the details using Form Kor Por. 3, as specified in this notification.
5. Advertising for medical devices that are not allowed to be advertised includes
   • The advertising of false or exaggerated benefits, quality, quantity, standards, components, or sources of medical devices, according to Section 59(1) of the Medical Device Act B.E. 2551, or containing statements that are prohibited for advertising as per Schedule 1 (which are “Best, excellent, special, miraculous, perfect, completely cured, worry-free, instantaneous, sacred, the safest, No.1, the best, definitely, superior, no worries, confident, opportunities like this don’t come often, no allergic reactions, no side effects, including any images conveying such meanings) attached to the announcement.
   • Advertising of medical devices with messages that are unfair to consumers or messages that may have negative effects on society.
     1. Inappropriate messages for the public or those that directly or indirectly support illegal or immoral acts.
     2. Messages that are misleading or contrary to morality or the good customs and traditions of Thailand, or that lead to damage to the national culture.
     3. Messages that overshadow or compare with the medical devices of other operators, except for comparisons with one’s own products or in academic contexts and must not mention trade names.
     4. Messages that express endorsement or praise for the benefits of medical devices by any individual.
     5. Messages that cause misunderstanding in the essential information about medical devices.
     6. Messages that encourage the excessive or inappropriate use of medical devices, resulting in potential harm from use, or that create an impression that it is suitable for regular use.
6. The advertising of medical devices must be carried out according to the following criteria:
   • Advertising of benefits, quality, quantity, standards, components of medical devices that manufacturers or importers must be licensed, Listing, or Notification, can only advertise those that have been licensed, Listing, or Notification.
   • The advertising of medical devices that must be sold only to healthcare facilities or heathcare professionals under Section 6 (10) of the Medical Device Act B.E. 2551 can be advertised to the general public only if it is demonstrated that consumers are involved in the decision-making process of using that type of medical device on their bodies.
   • The advertising of medical devices must at least display the following information:
     1. 1. Name of the medical device
     2. 2. Advertiser’s name and contact information, except on promotional materials or giveaways
     3. 3. The advertisement license number must be clearly displayed, except on promotional materials or giveaways
     4. 4. The listing, notification license number or registration number of the establishment that manufactures or imports medical devices prior to the ministry regulation effective in 2020, except on promotional materials or giveaways
     5. 5. Warning messages, prohibitions, precautions as applicable, as follows:
        – In case of advertising to the general public, a message “Notice the warnings on the label and accompanying documents before use” must be clearly displayed, alongside detailed warnings, prohibitions, and precautions for the medical device as applicable, except in promotional materials or giveaways or billboards- In case of advertising to healthcare professionals and health officials, the message “Advertise to Healthcare Professional and Health Official” must be clearly displayed

        – It must be able to be presented in an easily accessible electronic format, such as a QR code or any other electronic format that can read the data.

7. The advertising of medical devices has the following conditions:
   • Advertisements must only include messages, target groups, and communication channels that are explicitly permitted.
   • The duration must not exceed 3 years from the date of license issuance, or as specified in the license, unless there are amendments to the details that render the permitted messages unusable or if the license is revoked.
8. The submission of requests, permissions, or any contacts, as well as the issuance of documentation according to this announcement, shall be conducted in accordance with the law on electronic administrative procedures.

For additional details, please refer to the regulation

Comparison Table: Medical Device Advertisement Regulations between B.E.2564 (2021) and B.E.2568 (2025)