Who May Hold the Licence and Act as Importer in Thailand

Q: Can a foreign manufacturer hold its own device licence in Thailand?

1. Key takeaways

Thailand does not allow foreign manufacturers to hold medical device registration certificates in their own name. The law requires that only a Thai entity, duly established under Thai law and holding an Establishment License — Importer, may submit product registration, hold the registration certificate and handle importation. The Thai FDA has stated clearly on its official FAQ that foreign entities or individuals must appoint a Thai local authorised representative, and that the representative must be a Thai resident or a Thai-registered entity. Understanding this rule is the starting point for every compliant Thailand market-entry plan, because it determines who signs, who pays, who imports and who answers to the regulator throughout the entire product lifecycle.

• Foreign entities cannot self-hold. Only a Thai legally established entity holding the Establishment License — Importer may register the product, hold the certificate and conduct importation.
• A local authorised representative is mandatory. Per the Thai FDA official FAQ, the representative must be a Thai resident or a Thai-registered entity.
• The three-in-one structure is binding. Licence holder, importer of record and authorised representative are tied to the same legal entity; any structure that separates these three roles does not stand under Thai law.
• Import is a regulated extension of market authorisation. The policy logic is that one product must have one accountable legal entity, not a neutral administrative arrangement.
• Fund flows follow the same logic. Where business activity takes place in Thailand, payment should be completed in Thailand, with VAT accrued and paid there before remittance to the manufacturer under a compliant agreement.
• EU authorised representative thinking is the most common structural error. The Thai licence holder combines certificate ownership, actual importation and the statutory regulatory contact point, and the three cannot be separated.

2. Legal basis

The requirement rests on the establishment licensing provisions of the Medical Device Act B.E. 2551 (2008) and on the Thai FDA official FAQ, which addresses in its first question that manufacturing or importation requires both an establishment licence and a product licence, and in its second question that foreign entities must appoint a Thai local authorised representative. The official For Commercial Purpose guidance on the Thai FDA website walks through Step 3, the establishment licence, and Step 5, product registration, in that order, confirming that the licensed Thai entity sits at the centre of both procedures. Thai Customs separately requires an importer of record for clearance, and Thai tax law contains the principle that VAT is accrued on economic activity conducted within Thailand, with specific application subject to the interpretation of the tax authorities. The practical consequence of these layered rules is that the Thai entity which holds the certificate is, by design, the same entity that imports, declares to customs and answers regulatory questions.

Under the Thai system these three functions are bound to a single legal entity. Any structure that tries to split them apart does not stand under Thai law. Common non-compliant patterns include a third-party importer importing on behalf of the certificate holder, a distributor importing under informal arrangements, and a logistics company acting as a nominal importer. These patterns lack regulatory legitimacy and cannot pass a substance-over-form review, because in each case the entity named on the certificate is not the entity actually performing the regulated activity.

3. Expert insights

The reason the roles must stay together lies in the underlying policy logic: one product must have one accountable legal entity. Importation in Thailand is not a neutral administrative act; it is a regulated extension of the market authorisation itself. If the importer is not the licence holder, responsibility is fragmented, so when a problem arises it becomes unclear who is responsible; corrective action is delayed, because recalls and vigilance measures cannot be executed quickly across a split chain; and enforcement responsibility becomes unclear, because the regulator cannot determine against whom penalties should be imposed. This is also the essential difference from the European Union model. The EU authorised representative is an independent role that may carry only liaison obligations while holding no certificate and importing nothing. The Thai licence holder, by contrast, is the rights holder on the certificate, the actual importer and the statutory contact point, all at once, and the three are inseparable. Designing a Thai structure with EU authorised representative thinking is therefore the most common structural mistake seen in this market, and it usually surfaces only after commercial operations have already begun, when correcting it is costly.

4. Practical recommendations

• Ask one question first. When designing a Thai structure, ask whether holding the licence, importing and receiving payment are performed by the same Thai entity. If the answer is no, the structure carries exposure on both the regulatory and the tax dimension.
• Do not rely on paper-entity arrangements. Any arrangement in which the distributor pays an offshore certificate-holding entity, funds bypass Thailand, or the licence-holding party is merely a paper entity carries tax compliance risk and lacks regulatory legitimacy.
• Follow the compliant fund flow. The compliant path is that the Thai distributor pays the licence holder, VAT is accrued and paid in Thailand, and the licence holder then remits to the manufacturer under a compliant agreement.
• Settle this decision before technical details. This question determines earlier than any technical detail whether the project can run stably over the long term, so it belongs at the top of the entry plan, not in the annexes.
• Reject informal import arrangements. Distributor informal imports and logistics companies acting as nominal importers cannot withstand a substance-over-form review and should be excluded from any proposed structure.
• Align contracts with the structure. Agreements with distributors and service providers should reflect the same-entity principle so that contractual flows, customs declarations and regulatory filings tell one consistent story.

5. Verification checklist

• □ Thai FDA official FAQ, question 1 (manufacturing or importation requires both an establishment licence and a product licence) and question 2 (foreign entities must appoint a Thai local authorised representative)
• □ Establishment licensing provisions of the Medical Device Act B.E. 2551 (2008)
• □ Thai FDA website For Commercial Purpose Step 3 (establishment licence) and Step 5 (product registration)
• □ Thai Customs requirements on the importer of record
• □ Thai tax law principle on VAT accrual for economic activity within Thailand (specific application subject to the tax authority interpretation)

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