Thailand · FDA registration
Local authorized representative in Thailand
The Thai FDA issues licenses and registrations only to Thai companies, so a foreign manufacturer appoints a local authorized representative to hold them. Who holds your registration decides how freely you can change distributors.
Overview
Understanding the local authorized representative
A local authorized representative, or LAR, is the Thai legal entity that holds your FDA license and product approval when you have no company of your own in the country. It submits the application, holds the registration, and acts as the importer, which includes pulling the permit for each shipment. It also carries the post-market duties and is the point of contact for the Thai FDA.
Only a Thai national or a locally registered company can hold the underlying license, whether that is a medical device establishment license or a cosmetic importer license. The foreign manufacturer appoints the representative through a Letter of Authorization issued on its own letterhead, signed and stamped.
Because your approval sits with whoever holds it, the choice of representative is a commercial decision as much as a regulatory one.
By product
What the representative holds in each category
The role is the same across the FDA; the license it holds changes with the product.
| Product type | License the representative holds | What it registers |
|---|---|---|
| Medical devices | Establishment license | The device listing, notification, or license |
| Cosmetics | Cosmetic importer license | The product notification |
| Food and supplements | Food import license | Product registration for controlled foods |
| Drugs | Drug importer license | The marketing authorisation |
Different licenses, one role: a Thai entity holds your approval and answers to the FDA for it.
Your options
Ways to hold your registration
Every route puts the registration with a Thai entity. They differ in how much control you keep.
Register under your own entity
You set up a Thai company and hold the licenses yourself. This gives full control, with the capital and upkeep of running a local company.
Emerhub as your representative
We hold the license and the registration through our Thai entity as your local authorized representative. You keep control and can sell through any distributor.
A distributor as holder
Your distributor holds the registration. It is the fastest way in, but it ties your market access to one partner.
Keeping control
The risk of a distributor-held registration
The registration is what lets a product be imported and sold. When a distributor holds it, that asset sits on their side of the table, and your access to the market runs through one partner.
Thailand is more forgiving than some of its neighbors here. A manufacturer can appoint more than one representative, and since 2024 the FDA allows registrations to be transferred between Thai importers, so switching no longer always means starting over. Even so, the cleanest position is to keep the registration out of any distributor’s hands from the start.
An independent representative keeps the registration neutral. It holds your approval without competing as your distributor, so you can issue Letters of Authorization to several distributors at once and replace any of them without putting your registration at risk.
Responsibilities
What the representative is responsible for
Holding the registration is an ongoing duty, not a one-time filing.
- Holding the establishment or import license and the product approval
- Filing the registration, renewals, and variations
- Acting as importer, including the permit for each shipment
- Keeping Thai labels matched to what was approved
- Post-market surveillance and adverse-event reporting
- Managing recalls and field actions for the product
- Being the Thai FDA’s point of contact for the product
- Notifying the FDA of any change of holder
The process
How Emerhub acts as your representative
From a Letter of Authorization to a registration that stays in your control.
Step 1 — Issue a Letter of Authorization
You appoint Emerhub as your representative for the products in scope, through a signed Letter of Authorization.
Step 2 — Register under our license
We register, notify, or list your product under our Thai establishment or import license.
Step 3 — We import and hold it
We act as importer of record and hold the approval as your representative, handling renewals and reporting.
Step 4 — Keep distribution open
You issue authorizations to your distributors and change them without losing the registration.
Common questions
Local representative questions
What foreign manufacturers ask about holding a Thai registration.
Can a foreign company hold a Thai FDA registration directly?
No. The Thai FDA issues licenses and registrations only to companies registered in Thailand. A foreign manufacturer sets up its own Thai entity or appoints a local authorized representative to hold them.
What is a Letter of Authorization?
It is the document a foreign manufacturer issues on its own letterhead, signed and stamped, authorizing the representative to hold the license and register the product on its behalf. The FDA requires it in every case.
Can I appoint more than one representative?
Yes. Thailand allows multiple holders for the same product. Each representative registers the product separately, with its own fees, unless the registration is transferred. An independent holder can also issue authorizations to several distributors under one registration.
What happens if I change representative?
Any change of holder is notified to the FDA. Since 2024 the FDA allows registrations to be transferred between importers, so depending on how the original was filed, you may not have to register again from scratch.
Does my representative control my product?
No. You keep ownership of the product and your commercial relationships. An independent representative such as Emerhub holds the approval in neutral hands and does not compete as your distributor, so you can change distributors without losing the registration.
On the ground in Bangkok
Talk to our Thailand team
Tell us the product, the regulator it falls under, and the distribution arrangements you have today. Our Bangkok team will hold your license and registration in neutral hands and keep the approval in your control as your channel arrangements evolve.
Emailthailand@emerhub.com
Phone+66 92 554 5444
OfficeUnited Business Center II
591 Sukhumvit 33, Watthana
Bangkok 10110
591 Sukhumvit 33, Watthana
Bangkok 10110