Thai Establishment Licence: Importer and Manufacturer Requirements

1. Key takeaways

The establishment licence is a licence over the Thai business premises itself, issued in two types: Importer and Manufacturer. Any entity that wishes to manufacture or import medical devices in Thailand for commercial purposes must first register with the Thai FDA and obtain an establishment licence. It is the precondition for licence holding and for import: every product registration application must be submitted by an entity that already holds the corresponding establishment licence, which makes it the true entry gate of the Thai system rather than a parallel formality. In the words used throughout this series, no establishment licence means no filing, and no filing means no market.

• Eligibility is narrow: the licence is granted only to companies duly established in Thailand or Thai nationals. Foreign manufacturers cannot apply and cannot hold it directly, which is precisely the legal reason a Thai local licence-holding entity must be appointed.
• The Thai FDA states officially that foreign entities or individuals must appoint a Thai local authorised representative, and that the representative must be a Thai resident or an entity duly registered in Thailand.
• The hard threshold in the application process is the on-site inspection: office and warehouse premises must meet the Thai FDA storage and quality system requirements, and the inspection should be scheduled as early as possible.
• Official fees for a 5-year licence, as published on the Thai FDA website, total 14,100 baht for a manufacturer licence and 16,100 baht for an importer licence.
• Validity is 5 years. Since July 2025 the Thai FDA operates a unified renewal system: renewals of establishment licences and registration certificates are handled in the SKYNET system within the annual window from 1 October to 31 December.
• Renewal official fees for the import licence are approximately 12,000 plus 4,000 baht.

2. Legal basis

The establishment licence regime rests on the establishment licence provisions of the Medical Device Act B.E. 2551 (2008), operationalised through the Thai FDA For Commercial Purpose process at Step 3. The published fee schedule, valid for a 5-year licence, is as follows.

Two accompanying requirements complete the legal picture. First, the eligibility restriction: only Thai companies or Thai nationals may be granted the licence, and the Thai FDA FAQ confirms that foreign entities must appoint a Thai local authorised representative who is a Thai resident or a Thai-registered entity. Second, the inspection requirement: the premises must pass the on-site inspection against the storage and quality system requirements before the licence issues, which is why the inspection is described in practice as the only step in the establishment licence process that cannot be compressed. Fees themselves are modest; the cost driver is preparation and waiting time, not money.

3. Expert insights

For a foreign manufacturer, the licence structure answers a question that arises in nearly every market-entry discussion: why can we not simply hold the registration ourselves? The answer is structural, not administrative. Because the establishment licence is granted only to Thai companies or Thai nationals, and because every product registration must be filed by an entity holding the corresponding licence, the licence-holding role necessarily sits with a Thai entity, and the foreign manufacturer participates through authorisation. The scheduling insight matters more than the fee figures.

Many project plans treat product registration as the critical path and leave the establishment licence as an assumed prerequisite, forgetting that the licence contains an on-site inspection whose scheduling is outside the applicant’s control. Premises preparation, appointment waiting and the inspection itself all sit upstream of any filing, so a plan that starts the licence late will slip regardless of how fast the dossier is built. The correct sequencing is to start the establishment licence first, covering site preparation and inspection, and then to start product registration; the two can run partly in parallel, but the licence step can never be deferred to the end. A practical estimate is that the establishment licence plus its inspection consumes more calendar time than teams expect, precisely because its timeline is set by the authority rather than by the applicant. Teams that plan around dossier speed alone routinely rediscover this the hard way, when a finished dossier sits waiting for a licence that has not yet been inspected.

4. Practical recommendations

• Start the establishment licence process at project kickoff, before any dossier work, and treat the inspection scheduling as the first milestone to lock.
• Prepare office and warehouse premises against the Thai FDA storage and quality system requirements well ahead of the inspection appointment.
• Confirm early that the licence-holding entity is a Thai company or Thai national, and that it will hold the importer licence when products will be imported.
• Budget the published fee schedule exactly: 100 plus 12,000 plus 2,000 baht for the manufacturer licence and 100 plus 12,000 plus 4,000 baht for the importer licence, each valid for 5 years.
• Put every licence into the SKYNET renewal calendar for the 1 October to 31 December window in the expiry year, with renewal fees of approximately 12,000 plus 4,000 baht for the import licence.

5. Verification checklist

• □ Thai FDA website For Commercial Purpose Step 3, establishment licence fee schedule, manufacturer 14,100 baht and importer 16,100 baht (pending verification).
• □ Medical Device Act B.E. 2551 (2008), establishment licence provisions confirmed (pending verification).
• □ Thai FDA website FAQ question 2, foreign entities must appoint a Thai local authorised representative (pending verification).
• □ Thai FDA unified renewal system via SKYNET, annual window 1 October to 31 December, effective since July 2025 (pending verification).
• □ Thai FDA on-site inspection requirements for office and warehouse premises (pending verification).

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