Medical Device Registration in Thailand

Medical device registration in Thailand is regulated by the Thai Food and Drug Administration (Thai FDA) under the Medical Device Act B.E. 2551 and subsequent amendments.
The registration pathway depends on product classification, intended use, risk level, and the role of the local entity responsible for regulatory compliance.

This page provides a technical overview of the Thai FDA registration framework, focusing on classification logic, submission routes, and regulatory responsibilities, without commercial intent.

Thai FDA Medical Device Classification

Medical devices in Thailand are classified according to risk-based criteria defined by the Thai FDA. The classification determines the applicable regulatory pathway, documentation requirements, and approval timelines.

The main categories include:

  • Low-risk medical devices

  • General medical devices

  • Notified medical devices

  • Licensed medical devices

Correct classification is a prerequisite for any Thai FDA registration process and directly impacts dossier structure and submission strategy.

Registration Pathways and Submission Routes

Depending on classification, medical devices may be subject to:

  • Notification

  • Listing

  • License-based registration

Each pathway follows a specific Thai FDA submission route, including format requirements, review stages, and post-market obligations.
Understanding these pathways is essential before engaging in medical device regulatory services in Thailand.

Role of the License Holder in Registration

Thai FDA regulations require that medical devices be registered under a locally established legal entity acting as license holder responsible of Thailand Medical Device Distribution.
The license holder is legally responsible for:

  • Product compliance

  • Regulatory submissions

  • Post-market surveillance

  • Communication with the Thai FDA

The selection and structuring of the license holder is a core regulatory decision, not a clerical step, within the overall medical device registration in Thailand.

Documentation and Technical Dossier Requirements

While specific documentation varies by classification, a typical Thai FDA technical dossier may include:

  • Device description and intended use

  • Risk analysis

  • Labeling and IFU

  • Clinical or performance evidence

  • Quality system documentation

Dossier alignment with Thai FDA expectations reduces review cycles and supports long-term regulatory sustainability.

Timelines and Regulatory Considerations

Approval timelines for medical device registration in Thailand are influenced by:

  • Device classification

  • Dossier completeness

  • Regulatory history of the product

  • Responsiveness during review

Manufacturers entering the Thai market should consider registration as part of a broader Thailand medical device market entry strategy, rather than as a standalone administrative task.

From Regulatory Framework to Practical Implementation

While this site focuses on the technical and regulatory structure, real-world implementation often requires coordination with experienced local operators.

Manufacturers seeking applied regulatory support may refer to medical device regulatory services in Thailand provided by specialized advisory firms operating locally.