MEDICAL DEVICE REGISTRATION

Medical Device Registration in Thailand

Registering a medical device in Thailand involves specific steps and adherence to Thai FDA regulations. Here’s a detailed overview of the process to ensure compliance and a successful registration.

Steps for Medical Device Registration in Thailand

Obtain an Establishment License
- Only Thai nationals or locally registered companies are eligible to apply for this license.
- The Establishment License is mandatory before proceeding with device registration.
Classify the Device’s Risk
- Determine the risk class of your medical device (Class 1, 2, 3, or 4) as per Thai FDA guidelines.
- Risk classification dictates the documentation and evaluation requirements.
Submit Required Documentation Online
- Use the Thai FDA’s Pre-submission and E-submission systems to upload your documents.
- Ensure all forms and technical dossiers are complete and accurate.
Pay the Required Fees
- Fees vary depending on the risk classification and registration route chosen.
Thai FDA Document Evaluation
- The Thai FDA reviews the submitted documents.
- If additional information or corrections are needed, the Thai FDA will issue a request.

Registration Routes

The Thai FDA offers different pathways depending on the device class and evaluation requirements:

Full Evaluation
- Applicable to Class 2, 3, and 4 medical devices.
- Requires submission of a complete dossier for comprehensive review.
Concise Pathway
- Available for Class 2, 3, and 4 medical devices.
- Designed to expedite the process and reduce evaluation costs.
Reliance Program
- For Class 2, 3, and 4 medical devices.
- Leverages approvals from recognized foreign regulatory agencies to speed up 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, which is the accepted language for Thai FDA documentation.

Why Choose Us for Medical Device Registration?

Navigating the Thai FDA’s regulatory landscape can be complex. Our team of experts simplifies the process, ensuring timely and accurate submissions. Whether you’re a manufacturer or importer, we help you bring your medical devices to the Thai market seamlessly.

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