Thai FDA License Holder

What is a Thai FDA License Holder

Under Thai medical device regulations, foreign manufacturers cannot directly hold Thai FDA licenses.

A local Thai entity is required to:

This role is commonly referred to as Thai FDA license holder.

The license holder is not a formal administrative detail, but a critical regulatory and commercial position.

Why the License Holder Matters

The Thai FDA license holder has legal responsibility for:

  • regulatory compliance

  • product changes and notifications

  • renewals and maintenance

  • adverse event reporting

  • inspections and authority communication

An inappropriate license holder structure may expose manufacturers to:

  • loss of registration control

  • commercial dependency on distributors

  • difficulties in changing partners

  • regulatory discontinuity

For this reason, the license holder must be selected strategically, not opportunistically, in full respect of regulatory responsibilities of a medical device license holder.

Common License Holder Models in Thailand

In practice, manufacturers usually encounter three models:

  • Distributor-held license
    Fast to start, high long-term risk.

  • Importer-held license
    Slightly better control, still commercially dependent.

  • Independent license holder
    Full regulatory continuity and commercial flexibility.

MedGate operates exclusively as an independent Thai FDA license holder, with no distribution or sales interests.

Independent License Holder vs Distributor

When a distributor holds the Thai FDA license:

  • changing distributor often means re-registration

  • regulatory leverage shifts away from the manufacturer

  • commercial disputes may escalate into regulatory deadlock

An independent license holder structure allows:

  • free choice of distributors

  • uninterrupted regulatory compliance

  • clean exit strategies

  • long-term market stability

This model is strongly recommended for manufacturers planning sustainable operations in Thailand.

MedGate License Holder Services

MedGate provides Thai FDA license holder services for medical devices, including:

  • license holding and maintenance

  • regulatory submissions and renewals

  • change management

  • post-market compliance

  • coordination with manufacturers and distributors

Our role is limited to regulatory representation, through Thai FDA Medical Device Registration Service.
We do not act as importer, distributor, or business developer.

Regulatory Continuity and Risk Management

License holder continuity is essential to:

  • protect existing approvals

  • avoid market disruption

  • ensure compliance during commercial changes

MedGate structures license holder arrangements to:

All activities are conducted in accordance with Thai FDA regulations and authority expectations.

Who Should Use an Independent License Holder

Independent license holder services are recommended for:

  • manufacturers entering Thailand for the first time

  • companies working with multiple distributors

  • manufacturers planning long-term market presence

  • companies seeking regulatory independence

This approach is particularly relevant for medium- and high-risk medical devices.

Start with a Regulatory Assessment

The optimal license holder model depends on:

  • device classification

  • commercial strategy

  • distribution structure

  • long-term market objectives

MedGate provides a preliminary regulatory assessment to define the most appropriate license holder strategy for Thailand.