Thailand (TFDA) Authorized Representative (AR)

Foreign manufacturers who do not have a legal entity in Thailand must appoint a Local Authorized Representative (AR) - sometimes called an in-country representative or marketing authorization holder – if they wish to register, import and sell medical devices or IVDs in Thailand. The local AR must be a Thai national or a locally established company with a valid Establishment License issued by the Thai Food and Drug Administration (TFDA).

An Establishment License is a critical requirement to ensure compliance with local laws and is mandatory for importing medical devices. The license authorizes the local AR to import and/or distribute medical devices in Thailand. The foreign manufacturer must also provide a Letter of Authorization (LoA) to the local AR. The LoA is a formal document confirming the local AR’s authority to act on the manufacturer’s behalf and is required during the registration process.

Manufacturers may appoint more than one local AR if desired, offering flexibility to manufacturers seeking market access in Thailand. However, each AR must independently register the product (which is treated as a new application, including registration fee), and meet all regulatory requirements.

Liaison with the Thai FDA

The local AR serves as your official point of contact with the Thai FDA and is responsible for acting on behalf of the manufacturer in all regulatory communications. This includes responding to authority inquiries to ensure efficient, accurate communication.

Registration & Documentation

Your AR is responsible for managing the full registration process, including the preparation and submission of technical documentation in the Common Submission Dossier Template (CSDT) format, which is submitted by the manufacturer.

The AR handles documentation activities related to regulatory submissions, renewals, and changes. This also involves ensuring correct product classification, coordinating e-submissions via Thai FDA systems, compiling all required documents and supporting evidence of safety and performance.

Compliance

The local AR is responsible for ensuring ongoing compliance with Thai regulations and the Medical Device Act (B.E. 2551 & 2562), following applicable product safety, quality, labelling (in Thai), and post-market surveillance (PMS) standards. This includes vigilance activities such as adverse event reporting, complaint handling, recalls and implementation of corrective actions when necessary. The Thai FDA may audit the manufacturer or local AR to verify QMS compliance with international standards (e.g., ISO 13485).

Importation

The AR holds the Establishment License, which is required for legally importing products into Thailand. This enables the AR to facilitate smooth importation processes, ensuring that shipments comply with approved registrations, and customs regulations. The AR also supports coordination with distributors to ensure compliant market distribution and uninterrupted product availability.