Establishment License

TH-Unique · Mandatory for all manufacturers and importers

What Is an Establishment License?

An Establishment License (ใบอนุญาตสถานประกอบการ) is a mandatory Thai FDA licence that every medical device manufacturer and every importer must hold before any product registration application can be submitted or any commercial activity can begin.

This is separate from product registration (Listing/Notification/License) — it is a licence for the company as an operator, not for a specific device.

Who Must Hold an Establishment License?

Operator Type	Establishment License Required
Thai manufacturer of any Class 1–4 device	✅ Yes
Commercial importer of any registered device	✅ Yes
Thai Authorized Representative holding product registration	✅ Yes
Distributor (in most cases)	Confirm with Thai FDA

Class 1 devices: Even for Class 1 Positive List devices (the simplest approval pathway), the manufacturer/importer must hold a valid Establishment License.

License Holder vs Product Registrant

The Establishment License and the product approval (Listing/Notification/License) are held by the same or related entities but serve distinct purposes:

Licence Type	What It Covers
Establishment License	The company's authorisation to operate as a manufacturer/importer
Product Listing/Notification/License	The specific device's authorisation to be placed on the Thai market

A company may hold one Establishment License covering multiple product registrations across different device types.

Establishment License Application

Requirements

Submit to Thai FDA / MDCD:

• Company registration documents (Thai corporate registration)
• Details of premises (address, facilities, storage conditions)
• Qualified person(s) — responsible person details
• Scope of operations (manufacturer / importer / distributor)
• For importers: relationship with foreign manufacturer (LOA)

Application Process

1. Submit application to Thai FDA/MDCD via e-submission system
2. Thai FDA reviews application
3. Site inspection may be conducted for manufacturing establishments
4. License issued upon approval

Establishment License Renewal

Establishment Licences must be renewed periodically. Track expiry dates — a lapsed Establishment License invalidates the ability to submit new product applications and may affect existing product approvals.

Thai Authorized Representative (AR) — TH-Unique

Foreign manufacturers who do not have a Thai entity must appoint a Thai Authorized Representative (AR) to hold the Establishment License and product registrations on their behalf.

AR Obligations

Obligation	Detail
Hold Establishment License	As the Thai-registered entity
Hold product approvals	Listing/Notification/License certificates
Maintain regulatory compliance	Ongoing post-market obligations
Interface with Thai FDA	Primary regulatory contact
Multiple importers/distributors	The AR may support multiple commercial entities distributing the same product

AR vs Importer

Under the Thai model, a manufacturer may appoint:

• One AR (holding the regulatory approvals)
• Multiple importers/distributors (handling physical importation and sales in different channels)

This is a distinctive feature — the separation of regulatory licence holder (AR) from commercial importers allows flexible distribution arrangements.

e-Submission System — TH-Unique

All Thai FDA registration applications are submitted through the Thai FDA e-submission online portal. There is no physical paper submission for new registrations.

Key Points About e-Submission

• An account must be created by the Thai AR or Thai-registered entity
• Applications are submitted, tracked, and managed through the portal
• Document upload requirements and formats are specified in the portal guidance
• Review status can be monitored online
• Approved certificates are issued electronically

The Thai FDA e-submission portal is available at the Thai FDA website. Confirm the current portal URL and technical requirements with your AR or from www.fda.moph.go.th.