Medical Device Advertising Compliance and Penalties in Thailand

Thailand operates a pre-approval system for medical device advertising. This page explains who may apply for an advertising licence, which media are covered, what content restrictions apply, the exhibition exemption introduced in 2025, the penalties for violations, and how enforcement against digital channels has intensified.

1. Key takeaways

No, a medical device advertisement cannot simply be published in Thailand. The country applies a pre-approval system: advertisements directed at the public or at healthcare professionals must obtain an Advertising License Number before publication. The Thai FDA website process makes this explicit: anyone wishing to publish a device advertisement must first obtain advertising approval. Applications may only be made by the Thai licensed holder of the registration, and foreign companies must submit through their Thai local authorised representative, consistent with the Thai structure in which the licence holder, the importer and the authorised representative are the same entity.

• Pre-approval. An Advertising License Number must be obtained before any advertisement is published.
• Who may apply. Only a holder with Thai legal entity status who has already obtained the registration certificate or product licence; foreign companies must apply through their Thai local authorised representative.
• Covered media. Television, radio, print media, outdoor advertising, websites, social media, email marketing, brochures, videos, exhibition booth panels and paid search advertising. In practice almost any commercial communication directed at an audience falls within the scope of advertising.
• Content limits. Content must be consistent with the approved intended use and labelling; claims exceeding the registered indications are not approved, and a registration change must be made first. False or exaggerated claims are prohibited.
• Exhibition exemption. A notification of 2 September 2025 introduced an exemption for exhibition booths, subject to conditions set out below.
• Penalties. Imprisonment and fines under Section 116 and related provisions, with suspension or revocation of registration and import licences for repeated violations.

2. Legal basis

The pre-approval requirement and the penalty framework rest on the advertising provisions of the Medical Device Act B.E. 2551 (2008), including the penalties of Section 116. The application pathway is documented on the Thai FDA website under the commercial purpose process, where advertising approval appears as Step 7, and the applicant must be the Thai licence holder or its local authorised representative. The exhibition exemption derives from the notification of 2 September 2025, which exempts device advertising during national or international scientific exhibitions with 100 or more participants and during academic conferences from the pre-approval licence, provided that the organiser gives prior notice to the Thai FDA of the event and the exhibits, and that the content contains no false or exaggerated claims, no endorsements, no lotteries or prize draws, and no prohibited disease claims. Enforcement against digital channels is carried out by the MDCD in cooperation with the Electronic Transactions Development Agency (ETDA), which monitors Thai-language digital channels and can request platforms to remove content. After the 2019 amendment, enforcement intensity has risen markedly.

The penalty structure has two tiers. Advertising without a licence carries up to six months of imprisonment, or a fine not exceeding 50,000 baht, or both, under Section 116, and each publication, and in certain circumstances each broadcast, may constitute a separate offence. Exaggerated or false publicity carries up to one year of imprisonment, or a fine not exceeding 100,000 baht. Repeated violations or violations involving false claims can lead to suspension or revocation of the registration certificate and the import licence.

3. Expert insights

The most important structural insight is that the advertising permission sits in the same hands as the registration itself. Because the applicant must be the Thai licence holder, and because content must match the approved intended use and labelling, the advertising review is effectively a second gate over the registered claims. Any commercial material that drifts beyond the registered indications fails at the gate, and the only lawful route forward is a registration change first.

The second insight concerns media scope. The enumerated list runs from television and radio through websites, social media and paid search advertising, and the practical reading is that nearly any commercial communication directed at an audience is advertising. Social media posts and paid search campaigns are the two categories most easily mistaken for non-advertising and pushed past the review, which makes them the most common sources of enforcement exposure. The exhibition exemption of 2 September 2025 narrows the pre-approval requirement for qualifying scientific exhibitions with 100 or more participants and academic conferences, but it preserves the content prohibitions and requires prior notice to the Thai FDA, so it is an exemption from licensing, not from content control.

4. Practical recommendations

• Make an obtained Advertising License Number a precondition for the marketing department to release any promotional material, so nothing goes live before the licence exists.
• Sequence the workflow as follows: the marketing department prepares the material, the licence holder reviews it against the registered scope, the licence holder applies for the Advertising License Number, the number is obtained, and only then is the material published. Skipping any step leaves the responsibility on the licence-holding party, while the original manufacturer often only learns of the problem afterwards.
• Pay particular attention to social media and paid search advertising, the two channels most easily bypassed on the assumption that they are not advertising.
• Route all materials through the licence holder’s review even where the creative work is done abroad, since the application must be submitted by the Thai licence holder or its local authorised representative.
• For exhibition participation, verify whether the event qualifies as a national or international scientific exhibition with 100 or more participants or an academic conference, give prior notice to the Thai FDA of the event and exhibits, and screen all booth content against the four prohibitions on false or exaggerated claims, endorsements, lotteries and prohibited disease claims.

5. Verification checklist

• □ Confirm the advertising provisions of the Medical Device Act B.E. 2551 (2008) and the penalties of Section 116: advertising without a licence carries up to six months of imprisonment or a fine not exceeding 50,000 baht.
• □ Confirm the penalty for exaggerated or false publicity: up to one year of imprisonment or a fine not exceeding 100,000 baht.
• □ Confirm the Thai FDA website process under For Commercial Purpose, Step 7: advertising approval.
• □ Confirm the applicant for the Advertising License Number must be the Thai licence holder or the local authorised representative.
• □ Confirm the notification of 2 September 2025 on the exhibition exemption: national or international scientific exhibitions with 100 or more participants and academic conferences, with prior notice required and four content restrictions.
• □ Confirm cooperation between the MDCD and the ETDA in monitoring Thai-language digital channels.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Thailand. Our team prepares dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with the Thai FDA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com