On December 4, 2024, the Thai FDA announced revisions to the regulations governing medical device advertising. These updates, outlined in 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)”, aim to enhance clarity and ensure alignment with current regulatory and advertising practices.
The revised regulation took effect on January 4, 2025.
The revised regulation took effect on January 4, 2025.
Section 1: Effective Date
The revised regulations are effective immediately following their publication in the Government Gazette.
Section 2: Revocation of Previous Regulations
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) is officially revoked.
Section 3: Exemptions
This announcement does not apply to advertisements of medical devices exempted from the requirement of permission under the Ministry of Public Health (MOPH) notifications, including:
- Criteria for Medical Device Advertising Exempted from Advertising Permission (B.E. 2563), dated September 22, 2020.
- Criteria, Conditions and Requirements for Advertising Medical Devices Directly to Healthcare Professionals and Health Officials Exempted from Advertising Permission (B.E. 2563), dated August 26, 2020.
- Other Ministry of Public Health notifications related to exemptions for medical device advertising permissions.
Section 4: Licensing Requirements
- Application Requirements:
Any person or entity intending 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.
Section 5: Prohibited Practices
- False or Exaggerated Claims:
- Advertising benefits, quality, quantity, standards, ingredients, or sources of a medical device in a manner that is false or exaggerated.
- Unfair or Harmful Content:
- Messages indecent to the public or encouraging illegal or immoral acts.
- Messages misleading or contrary to morality or the good cultural traditions of Thailand.
- Content leading to the degradation of national culture.
- Unfair Comparisons:
- Advertisements insulting or comparing medical devices from other operators.
- Comparisons are only allowed when comparing the advertiser’s own products or in academic contexts without mentioning trade names.
- Endorsements:
- Messages that endorse or praise the benefits of a medical device by any person.
- Excessive Use Promotion:
- Messages encouraging excessive or inappropriate use of medical devices, potentially causing harm or creating a perception that they are suitable for regular use.
Section 6: Advertising Criteria
- Accuracy of Advertising Content:
- Advertising must include only benefits, quality, and details that are licensed, notified, or listed.
- Mandatory Inclusions:
- Advertisements must clearly display:
- Name of the medical device.
- Name and contact information of the advertiser, except on giveaways or souvenirs.
- Advertising license number, except on giveaways or souvenirs.
- Advertisements must clearly display:
- Warnings and Precautions:
- Public advertisements must display:
Notice the warnings on the label and accompanying documents before use* along with warnings, contraindications, and precautions, as applicable. - Healthcare professional advertisements must include the statement:
“Advertise to Healthcare Professional and Health Official.”
- Public advertisements must display:
- Electronic Formats:
- Required information may also be displayed in electronic formats, such as QR codes or other easily accessible electronic methods.
Section 7: Advertising Conditions
- Compliance with Licensing Terms:
Advertisements must use only approved messages, target audiences, and communication channels. - License Validity:
Licenses are valid for up to three years unless revoked or altered due to regulatory changes affecting the content.
Section 8: Application and Electronic Procedures
- Advertising Media Restricted to Specific Areas:
- For Bangkok: Applications must be submitted to the Food and Drug Administration office.
- For other provinces: Applications must be submitted to the respective Provincial Public Health Office.
- General Advertising:
Applications for unrestricted advertisements must be submitted to the Food and Drug Administration or locations designated by the Secretary General.
Section 9: Validity of Existing Licenses
Licenses issued prior to the effective date of this announcement will remain valid until their expiration or revocation.
Section 10: Applications Under Review
Applications submitted before January 4, 2025, and under review will be processed according to this notification. Corrections or additional documents may be requested to comply with the new guidelines.
Annex 1: Prohibited Language
Prohibited terms in advertising include:
- “Best,” “perfect,” “number one,” “complete healing,” “safe,” “miraculous,” and similar claims.
- Images that imply prohibited claims or meanings.
Compliance Advisory
Medical device manufacturers and importers are urged to ensure their advertisements comply with the updated regulations.
For detailed information, refer to: กองควบคุมเครื่องมือแพทย์ (Thai FDA Official Website in Thai).
For inquiries regarding this announcement, please reach out to our team at sales@andamanmed.com or click the button below to contact us.
For detailed information, refer to: กองควบคุมเครื่องมือแพทย์ (Thai FDA Official Website in Thai).
For inquiries regarding this announcement, please reach out to our team at sales@andamanmed.com or click the button below to contact us.