MEDICAL DEVICE REGISTRATION

Medical Device Registration in Thailand

Registering a medical device in Thailand requires full compliance with Thai FDA regulations. Our Regulatory Team guides you through every step of the medical device registration process to ensure timely approval and compliance.

Steps for Medical Device Registration in Thailand

1. Obtain an Establishment License

Only Thai nationals or locally registered companies acting as a License Holder can apply. This license is mandatory before proceeding with medical device registration.

2. Classify the Device’s Risk

Determine the risk class of your medical device (Class 1, 2, 3, or 4) according to Thai FDA guidelines. The risk classification defines the required documentation and evaluation process.

3. Submit Required Documentation Online

Use the Thai FDA’s Pre-submission and E-submission platforms to upload all technical dossiers and forms. Accurate and complete submissions accelerate the device registration process.

4. Pay the Required Fees

Fees vary depending on device class and registration pathway. Proper fee submission ensures your medical device registration proceeds without delays.

5. Thai FDA Document Evaluation

The Thai FDA reviews all submitted documentation. Requests for additional information or corrections may be issued, and timely responses are essential for smooth approval.

Registration Pathways for Medical Devices

Depending on device classification, the Thai FDA provides several registration routes:

Full Evaluation

For Class 2, 3, and 4 devices.
Requires a complete dossier for comprehensive review.

Abridge Pathway

For Class 2–4 devices.
Allowed if your device got obtained registration from at least 12 months from EU, USA, Canada, Japan or Australia.
Designed to expedite the registration process and reduce evaluation costs.

Reliance Program

For Class 2–4 devices.
Leverages approvals from Singapore (and soon Malaysia) regulatory authorities to accelerate medical device registration.

Key Registration Requirements

Compliance with the Medical Device Act B.E. 2551 (2008) and its amendment B.E. 2562 (2019) is mandatory.
All submissions must be in English, the official language for Thai FDA documentation.
Documentation must match the device’s classification and chosen registration pathway.

Why Choose a Strategic Partner and Regulatory Team?

Navigating Thai FDA regulations can be complex. A reliable Strategic Partner and experienced Regulatory Team help simplify the medical device registration process, ensuring timely submissions and approvals. Whether acting as a License Holder or coordinating submissions, expert guidance ensures your devices reach the Thai market efficiently. The cost of License Holding and registration, calculated based on number of devices, duration of license holding, and device risk class, is generally modest compared to the strategic advantage of timely market access.

Contact us today to start your medical device registration in Thailand journey.