LICENSE HOLDING IN THAILAND

License Holding in Thailand: A Comprehensive Overview

License holding in Thailand refers to a legal arrangement where a local Thai entity acts as the registered holder of licenses required to operate a business on behalf of a foreign company. This setup is common in regulated industries such as medical devices, cosmetics, dietary supplements, and food products, where compliance with Thai FDA regulations is mandatory. By relying on a local Strategic Partner as the license holder, foreign businesses can operate in Thailand without establishing a fully local subsidiary.

Key Aspects of License Holding in Thailand

Foreign Business Limitations

Thailand’s Foreign Business Act restricts direct foreign ownership and operation in certain industries. Using a License Holder allows foreign companies to meet regulatory requirements efficiently.

Regulatory Compliance

The local license holder ensures full adherence to laws covering product registration, import processes, and post-market surveillance, across all product categories including medical devices, cosmetics, dietary supplements, and food products.

Advantages for Foreign Companies

Easier Market Entry: Access the Thai market without creating a local entity.
Reduced Administrative Burden: Your local partner manages licensing applications, renewals, and documentation.
Cost Efficiency: A simpler and more affordable solution than establishing a fully owned subsidiary.

Common Applications of License Holding

Medical Device Import: Thai companies can hold FDA licenses for foreign manufacturers, ensuring compliance.
Cosmetic Distribution: Foreign cosmetic brands appoint Thai partners for import and distribution licenses.
Dietary Supplements & Food Products: Local license holders manage registration, labeling, and import approvals.

Important Considerations

Choosing the Right Partner: Select a reputable Strategic Partner experienced in the relevant industry and Thai FDA processes.
Contractual Agreements: Define clear roles, responsibilities, and liabilities between the foreign company and license holder.
Market Expertise: A local license holder provides valuable insights into consumer preferences and market trends.

By leveraging license holding, foreign companies can navigate Thailand’s regulatory landscape efficiently, maintaining compliance across all product types while reducing operational complexity.

Our License Holding Services

Our Regulatory Team provides comprehensive License Holding services across all regulated products. With our team, you can expand confidently in Thailand without needing a physical presence or local legal entity. The immediate quotation for License Holding, calculated based on the number of devices, duration, and risk class, is generally modest compared to the strategic and economic advantage of timely market access.

Our Services Include:

Thai FDA Product Registration – for medical devices, cosmetics, dietary supplements, and food products.
Labeling Compliance – ensure labels meet Thai FDA standards, including language, format, and ingredient accuracy.
Document Preparation & Submission – compile and submit technical dossiers and supporting documents.
License Holding Services – act as your official Thai FDA license holder for compliance and regulatory representation.
Importer License Assistance – obtain importer licenses for regulated products.
Regulatory Consultation – expert guidance on Thai FDA regulations and market entry strategies.
Post-Approval Compliance – ongoing support to maintain regulatory compliance.
Regulatory Updates & Notifications – stay informed about Thai FDA law or policy changes.
Renewals & Modifications – manage license renewals, product updates, and other modifications.
End-to-End Online Process – digital workflow from document collection to receiving licenses.

With this comprehensive approach, our Regulatory Team ensures your license holding and regulatory compliance journey is smooth, allowing you to focus on growing your business in Thailand.