Thailand · FDA registration
FDA import license in Thailand
Before any product can be registered with the Thai FDA, a local company has to hold a license to import it. This is the company-level license that clears FDA-controlled goods through customs, and it comes first.
Overview
Understanding the Thai FDA import license
The import license is the company layer of Thai FDA control. The FDA licenses a local entity for the activity it carries out, whether that is importing or manufacturing a regulated product category, and this page covers importing, the route most foreign brands take. It is issued by the Thai FDA, not by Customs, and Customs then clears each shipment against it, so a product approval on its own does not let goods enter the country.
It also comes first in the sequence. You cannot register, notify, or list an individual product until the entity that will hold it has the import license in place. The order is always the same: a Thai entity, then the import license, then the product approval, then a compliant Thai label, then customs clearance.
The license is held by a company, the registration covers a product. One import license can sit under many product registrations, but every registration needs a licensed entity behind it.
By product
Types of FDA import licenses
The same idea carries a different official name and conditions in each category.
| Product type | What the license is called | Key condition |
|---|---|---|
| Cosmetics | Cosmetic importer license | Requires a physical office and warehouse in Thailand |
| Medical devices | Establishment license | Granted by activity: import, manufacture, or sell |
| Food and supplements | Food import license | Renewed every three years |
| Drugs | Drug import license | Held alongside the product marketing authorisation |
| Household hazardous substances | Operating license | For Types 2 and 3; Type 1 is a notification of facts |
Beyond import
Other approvals that can apply
Depending on the product and what you do with it, other approvals apply alongside the import license. Most are further FDA licenses; the TIS mark comes from a separate regulator.
TISI certification
For electrical, electronic, and other industrial goods, the TIS mark from the Thai Industrial Standards Institute. It sits outside the FDA, under the Ministry of Industry, and a Thai representative holds the certificate after factory inspection and lab testing.
Storage license
Covers the warehouse or premises where regulated stock is kept before it is sold.
Advertising license
A separate approval needed before you advertise, tied to the claims the FDA cleared at registration.
Distribution license
Permission to sell the approved product on inside Thailand once it has cleared.
Advertising needs its own license. Advertising a regulated product requires separate FDA approval, tied to the evidence and claims cleared at registration. And if you manufacture in Thailand rather than import, a manufacturing license takes the place of the import license.
Who holds it
Who can hold a Thai FDA import license
Only a company registered in Thailand can hold an import license. A foreign manufacturer cannot apply directly, so it either sets up its own Thai entity or appoints a local holder that already has one. The license carries real obligations: a registered office, and for cosmetics a physical warehouse, along with the records and reporting the FDA expects from the holder.
That physical and legal footprint is why most foreign brands appoint a local holder rather than build it themselves. The holder supplies the entity, the license, and the warehouse, and the brand simply files its products underneath.
Not sure whether to set up your own entity or use a holder? See how Thai FDA registration works, or talk to our Bangkok team about holding the license for you.
The process
Getting licensed to import
From the right license to products on the shelf.
Step 1 — Confirm the category
We identify the product category and the exact license it needs, since each carries different conditions.
Step 2 — Provide the entity
You set up a Thai company, or we hold the license through our local entity as your representative.
Step 3 — Obtain the license
We file for the import or establishment license with the Thai FDA and meet the office and warehouse conditions.
Step 4 — Register and import
With the license in place, we register your products under it and clear your first shipments.
Common questions
Import license FAQs
What importers ask before they file.
Is the import license issued by the FDA or by Customs?
By the Thai FDA. Customs does not issue it; Customs clears your shipments against the FDA license and product approval you already hold. Without the FDA paperwork, regulated goods are held at the border.
Do I need both an import license and a product registration?
Yes. The import license is the company-level permission to bring in a product type; the registration, notification, or listing approves the specific product. The license has to be in place before the product can be approved under it.
Can a foreign company hold a Thai FDA import license?
No. The license is issued only to a company registered in Thailand. A foreign brand sets up its own Thai entity or appoints a local holder, such as Emerhub, to hold the license and import on its behalf.
How long does an import license last?
It depends on the category. A food import license is renewed every three years, and medical device establishment licenses run on their own cycle. We confirm the term and handle renewals for the categories we hold.
Do I need a separate license to advertise the product?
Usually yes. Advertising a regulated product needs its own FDA approval, matched to the claims and evidence cleared at registration. It is separate from the import license and the product approval.
On the ground in Bangkok
Talk to our Thailand team
Tell us the product and where it is made. Our Bangkok team will classify it, hold the license through our local entity or yours, and run the registration through to approval.
Emailthailand@emerhub.com
Phone / WhatsApp+62 811 1053 9667
OfficeUnited Business Center II
591 Sukhumvit 33, Watthana
Bangkok 10110
591 Sukhumvit 33, Watthana
Bangkok 10110