We handle the entire FDA registration process for you, from documentation to approval, so you can launch in Thailand with confidence.
We provide licensing services for import/manufacturing facilities, food product registration, and product laboratory analysis submissions.
We provide factory/import facility registration, cosmetic product notification/registration, and full legal advisory services by experienced professionals in one place.
We assist with licensing for import/manufacturing facilities, product registration, sales license applications, and medical device advertising approvals.
We assist with import and storage facility licensing, hazardous substance registration (Type 1–4), and regulatory advisory services for hazardous products.
We assist with industrial product registration and certification (TISI), including advisory services to ensure compliance with mandatory standards.
Thai company registration Import/distribution / manufacturing licenses
Last reviewed: 18 September 2026
Thailand FDA registration is administered by the Food and Drug Administration under the Ministry of Public Health. It operates as five separate regimes, each with its own statute, its own establishment licence and its own product-level step. Foreign brands routinely assume there is one FDA process. There is not, and the regime your product falls into determines the entity you need, the premises you must hold and the calendar you are working to.
| Product class | Governing Act | Establishment step | Product step | Indicative lead time |
|---|---|---|---|---|
| Food and beverages | Food Act B.E. 2522 (1979) | Import licence (Form Orr.7) or manufacturing licence (Orr.2), against an inspected premises | Serial number or notification per SKU, class-dependent | 4 – 8 months |
| Food supplements | Food Act B.E. 2522 (1979) — supplements are regulated as a controlled food | Same Orr.7 / Orr.2 licence | Full product registration with formula, specification and label review | 6 – 12 months |
| Cosmetics | Cosmetics Act B.E. 2558 (2015) | Importer or manufacturer registration with the FDA | Notification per formula, with a notification receipt issued | 2 – 4 months |
| Medical devices | Medical Device Act B.E. 2551 (2008), amended B.E. 2562 (2019) | Establishment licence, class-dependent | Listing, notification or licence according to risk class I – IV | 3 – 12 months |
| Drugs | Drug Act B.E. 2510 (1967) | Import or manufacturing licence | Marketing authorisation per product | 12 – 36 months |
This is the single most consequential feature of the Thai regime, and it is the one foreign brand owners discover too late. An FDA product approval attaches to the entity that holds the establishment licence. If your Thai distributor holds the Orr.7 or the cosmetic importer registration, the distributor holds your registrations.
Change distributor and you do not transfer the portfolio. You re-register it from zero, through the new licence holder, at full cost and full lead time, with your products off shelf in the meantime. A supplement range of fifteen SKUs can therefore take the better part of a year to move.
An import or manufacturing licence issues against a physical address that the FDA has inspected. For food and supplements that means a warehouse or facility with compliant storage, temperature control where required and a documented quality system. The inspection cannot happen against a plan.
The commercial consequence is a cost nobody budgets: the lease must be signed and the site fitted out before the licence can exist, and the licensing window then runs on top. Brands that model the approval period as a zero-cost wait end up paying commercial rent on an empty warehouse for roughly three months.
Importing and distributing goods is a restricted service under the Foreign Business Act B.E. 2542 (1999). A majority foreign-owned company cannot simply be incorporated and start importing. Three routes are ordinarily available, and the choice interacts with the FDA timeline rather than sitting beside it.
Because the FDA licence issues to an entity at a premises, the corporate route sits on the critical path. A structure chosen in month four delays every product approval behind it. Our guidance on company registration in Thailand covers the incorporation step in detail.
| Stage | What happens | Typical duration | Runs in parallel with |
|---|---|---|---|
| 1. Classification opinion | Confirm the regime, the sub-class and the claim set your product can carry | 2 – 4 weeks | Structuring |
| 2. Entity and structuring | Incorporation, and the FBL or BOI route where foreign control is retained | 4 weeks – 6 months | Premises search |
| 3. Premises and fit-out | Lease, storage build-out, quality documentation | 6 – 12 weeks | Dossier assembly |
| 4. Establishment licence | Application, FDA inspection, licence issue | 6 – 12 weeks | — |
| 5. Product registration | Per-SKU registration or notification, label and claim review | 4 weeks – 6 months | Commercial launch prep |
| 6. Post-market compliance | Advertising approval, labelling, renewals, recall readiness | Ongoing | — |
| Workstream | What moves the effort |
|---|---|
| Entity and structuring | Whether a Foreign Business Licence or a BOI application is needed alongside the FDA workstream |
| Establishment licence | Product class, and whether the premises pass inspection first time |
| Product registration, per SKU | Class, novelty of the ingredients, and the claims sought |
| Advertising approval, per piece | Medium and claim content |
| Third-party costs | Laboratory testing, certified translation and legalisation, and how promptly the overseas manufacturer produces its certification |
Government fees are fixed by Ministerial Regulation and are a small fraction of the total. We scope each mandate in writing before work begins, so the engagement is priced against a defined workstream. Please contact us to discuss a specific product range.
Our regulatory practice acts for overseas food, supplement, cosmetic and device brands entering Thailand, and for Thai importers taking on foreign portfolios. On a typical mandate we give the classification opinion and the permitted claim set in writing at the outset. We select and implement the ownership structure with the FDA timeline in mind rather than in isolation. We hold the establishment licence application, attend the inspection, and run the per-SKU registrations. We review artwork and advertising before it is committed. Where a distributor relationship ends, we manage the transfer or re-registration so the portfolio moves with the least time off shelf.
Für deutschsprachige Hersteller und Markeninhaber: Die thailändische FDA-Zulassung wird nicht der Marke erteilt, sondern der lizenzierten thailändischen Gesellschaft an einer behördlich geprüften Betriebsstätte. Wer die Einfuhrlizenz hält, hält die Produktzulassungen — ein Wechsel des Distributors bedeutet in der Regel eine vollständige Neuregistrierung.
Unsere Kanzlei in Bangkok begleitet Lebensmittel-, Nahrungsergänzungs-, Kosmetik- und Medizinproduktehersteller von der Einstufung über die Gesellschaftsstruktur und das Foreign Business Licence bis zur Produktregistrierung und Werbefreigabe. Beratung auf Deutsch und Englisch. Kontakt aufnehmen.
Send us the formula, the country of origin certification and the claims you intend to make. We will confirm the regime your product falls into, the entity that should hold the licence, and a realistic date for first shipment. Related reading: Thailand FDA registration process and FDA food registration for overseas brands.
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If you are a global brand seeking to import and distribute products in Thailand, our Bangkok-based team provides structured, compliant, and efficient regulatory support.
We assist international clients worldwide with end-to-end Thailand FDA registration and comprehensive market entry advisory services.
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