Official Fees for Establishment Licences in Thailand

Q: How much does an establishment licence in Thailand cost?

1. Key takeaways

Establishment licence fees in Thailand are published on the Thai FDA website and the licence carries a five-year validity period. The manufacturer licence totals 14,100 THB and the importer licence totals 16,100 THB, and in both cases the composition tells a story: the application fee is a token 100 THB, while the onsite inspection fee of 12,000 THB accounts for roughly 75 to 85 percent of the total. The pricing logic is that formal review is nearly free and the substantive inspection is where the cost sits. This is why the onsite inspection slot is the step in the process whose schedule cannot be compressed, and why the surrounding costs that really shape the decision are premises, quality systems, personnel and time rather than the official fees themselves.

• Two licence types, two totals. The manufacturer establishment licence totals 14,100 THB and the importer establishment licence totals 16,100 THB, both with five-year validity.
• Inspection dominates the fee. The onsite inspection fee of 12,000 THB makes up about 75 to 85 percent of the total, showing that the core of the licence is premises compliance, not paperwork.
• The application fee is symbolic. At 100 THB it reflects the Thai pricing logic: formal review nearly free, substantive inspection is the cost.
• Official fees are not the decision driver. In the self-set subsidiary versus independent licence holder comparison, the 16,100 THB official fee barely affects the outcome; annual operating costs and inspection lead time do.
• Renewal runs on a fixed annual window. Renewal official fees for import are about 12,000 plus 4,000 THB, handled in the SKYNET system, with the window running from 1 October to 31 December each year.
• Sequence matters. The establishment licence comes first: every product registration must be submitted by an entity that already holds the corresponding establishment licence.

2. Legal basis

The fee figures come from the establishment licence fee schedule at Step 3 of the For Commercial Purpose guidance on the Thai FDA website. The licence is valid for five years, and the premises must meet Thai FDA storage and quality system requirements, with maintenance of GDPMD (good distribution practice for medical devices) or an equivalent quality management system expected on an ongoing basis. The published schedule is summarised below.

Beyond the official fees, the accompanying costs are usually the bigger part of the picture. Premises cost covers office and warehouse space that meets Thai FDA storage and quality system requirements. System cost covers maintaining GDPMD or an equivalent quality management system. Personnel cost covers qualified quality and technical staff. Time cost covers the scheduling of the onsite inspection. Renewal official fees for the import licence are about 12,000 plus 4,000 THB, also on a five-year cycle, handled in the SKYNET system within the window from 1 October to 31 December each year.

3. Expert insights

Two facts in the fee composition carry real analytical weight. First, the onsite inspection fee is the main body of the total, at 12,000 THB or roughly 75 to 85 percent, which signals that the core of the establishment licence is premises compliance rather than paper materials. Second, the application fee is extremely low at 100 THB, reflecting a pricing philosophy in which formal review is nearly free and the substantive inspection is the cost. Together these explain a practical feature of the process: the onsite inspection slot is the only substantive step in the licensing flow, and therefore its schedule cannot be compressed no matter how well the paperwork is prepared. The composition also clarifies the sequencing rule. The establishment licence comes before product registration: any product registration application must be submitted by an entity that already holds the corresponding establishment licence. For a company planning to set up its own Thai subsidiary, this means incorporation first, then premises preparation, then the establishment licence including the onsite inspection, and only then the start of product registration. This chain is what makes the self-set subsidiary model the longest in lead time. When comparing it against the independent licence holder model, the practical estimate should be built on a three-year total cost of ownership, and the 16,100 THB official fee should be set aside, because what actually drives the comparison is the annual operating cost of premises, personnel and systems, together with the lead time imposed by the inspection.

4. Practical recommendations

• Compare models on a three-year total cost of ownership basis. This practical estimate, rather than the official fee, produces a clear conclusion between the self-set subsidiary and the independent licence holder.
• Set aside the official fee in the comparison. The 16,100 THB establishment licence fee barely influences the decision; the premises, personnel and system annual operating costs do.
• Plan premises against Thai FDA requirements early. The site must satisfy storage and quality system requirements before the inspection, so facility decisions belong at the planning stage.
• Budget GDPMD maintenance as a running cost. Maintaining GDPMD or an equivalent quality management system is an ongoing obligation, not a one-off setup item.
• Respect the sequence. Incorporation, then premises, then establishment licence with its onsite inspection, then product registration; trying to reorder the chain only delays the project.
• Track the renewal window from day one. Renewal official fees for import are about 12,000 plus 4,000 THB on the same five-year cycle, handled in SKYNET within the 1 October to 31 December window each year.

5. Verification checklist

• □ Thai FDA website For Commercial Purpose Step 3 establishment licence fee schedule (manufacturer 14,100 / importer 16,100 THB)
• □ Composition: application fee 100 plus onsite inspection fee 12,000 plus certificate fee 2,000/4,000
• □ Validity period of five years
• □ Renewal official fees (import) about 12,000 plus 4,000 THB, handled in SKYNET, window 1 October to 31 December each year
• □ Thai FDA onsite inspection requirements (premises must meet storage and quality system requirements)
• □ GDPMD maintenance requirement

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