Thai FDA Inspections and Penalty Framework

Thai FDA inspections follow recognisable lines of enquiry, and the penalty framework behind them ranges from fines to licence revocation. This page maps the five inspection lines, the consequences of operating without a licence, the advertising penalty tiers, the grounds for suspension or revocation of a registration certificate, and which bodies execute inspections and enforcement.

1. Key takeaways

Inspections in Thailand typically proceed along five lines: entity qualifications, product market access, imports, labelling and instructions for use, and advertising and vigilance. Operating without a licence is a citable violation, because production, import and sale are each separately licensed. Advertising violations carry the penalties of Section 116, and repeated violations or false claims can lead to suspension or revocation of the registration certificate and the import licence, the heaviest consequence because it cuts off market access entirely.

• Entity qualification line. Whether a valid institutional licence is held, whether GDPMD is maintained, and whether the premises meet requirements.
• Product access line. Whether valid listing, notification or licence certificates exist, and whether specific products have obtained the required sales licence.
• Import line. Whether an LPI exists, whether the HS code and declared value are consistent, and whether the product models fall within the valid registered scope.
• Labelling line. Whether labelling conforms to the MoPH labelling notification B.E. 2568 (2025), covering Thai language for home-use devices, the eight required elements, UDI, and the 120-day affixing grace period.
• Advertising and vigilance line. Whether an Advertising License Number has been obtained, and whether adverse event and FSCA reporting has been completed.

2. Legal basis

The licensing structure rests on the Medical Device Act B.E. 2551 (2008), under which production, import and sale of devices are each subject to separate authorisation: production or import requires an institutional licence together with a product licence, and the sale of specific products requires a sales licence. Lacking any single link constitutes operation without a licence, and the consequences include cessation of operations, confiscation and the corresponding penalties. The advertising penalties are set by Section 116: advertising without a licence carries up to six months of imprisonment, or a fine not exceeding 50,000 baht, or both, with each publication capable of constituting a separate offence, while exaggerated or false publicity carries up to one year of imprisonment, or a fine not exceeding 100,000 baht. Section 55 paragraph 5 empowers the Secretary-General to seize non-conforming or unsafe devices and order mandatory recalls. The Thai FDA website FAQ describes the three licence types: institutional licence, product licence and sales licence. The labelling requirements derive from the MoPH labelling notification B.E. 2568 (2025), including the 120-day affixing grace period, and the Thai FDA transfer notification of 19 September 2024 sets out the circumstances in which a transfer will not be approved. Enforcement against Thai-language digital channels is carried out by the MDCD in cooperation with the ETDA.

3. Expert insights

Inspections are executed by the Thai FDA, handled by the MDCD, and include site inspections of the institutional licence, post-licensing supervision and market surveillance. The HPVC is responsible for publishing information on vigilance and recalls. The practical takeaway is that the five inspection lines correspond almost exactly to the statutory duty map of the licence holder, so an inspection is in effect a test of whether the licence holder has operationalised each duty.

On suspension and revocation, the answer is yes, certificates can be suspended or revoked. The triggering circumstances include repeated violations, false claims, failure to fulfil reporting obligations where the circumstances are serious, and devices that do not match the registered dossier or are unsafe, which triggers the seizure and mandatory recall powers of Section 55 paragraph 5. In addition, where a device has a history of serious adverse events or there are reasonable doubts about its quality, efficacy or safety, a transfer will not be approved, which functions in substance as another form of qualification restriction.

The deepest insight from practice is that being able to produce evidence of compliance and being factually compliant are two different things. An inspection is an evidentiary exercise, and a licence holder that cannot produce dated self-inspection records, licence documents, LPI records, label proofs and affixing records, Advertising License Numbers and vigilance report records is exposed, even if its actual conduct is compliant.

4. Practical recommendations

• Conduct an annual compliance health check, working through the five inspection lines one by one, and keep a dated self-inspection record for each line.
• The purpose of the health check is not to discover whether violations exist, but to establish whether evidence of compliance can be produced: the institutional licence, registration certificate status, LPI records, label proofs and affixing records, Advertising License Numbers, and vigilance report records.
• Organise the evidence so each of the five lines can be answered from a single folder during an inspection, rather than reconstructed from scattered systems afterwards.
• Verify that each product model currently on the market falls within the valid registered scope, since the import line checks models against the registered scope and the HS code and declared value against each other.
• Confirm the labelling evidence against the MoPH labelling notification B.E. 2568 (2025), including the home-use Thai language requirement, the eight required elements, UDI and the 120-day affixing grace period.
• Treat repeated violations and false claims as existential risks, because they can lead to suspension or revocation of the registration certificate and the import licence, cutting off market access entirely.

5. Verification checklist

• □ Confirm the advertising penalties of Section 116 of the Medical Device Act B.E. 2551 (2008) and the related penalty provisions.
• □ Confirm Section 55 paragraph 5: the Secretary-General’s seizure and ordered recall powers.
• □ Confirm the Thai FDA website FAQ first question on the three licence types: institutional licence, product licence and sales licence.
• □ Confirm the MoPH labelling notification B.E. 2568 (2025) and its 120-day affixing grace period.
• □ Confirm the Thai FDA transfer notification of 19 September 2024 on the circumstances in which a transfer will not be approved.
• □ 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