If you’re looking to import medical equipment into Thailand, you’ll need to get a Thai FDA license first. There’s paperwork, licenses, and specific rules from the Thai FDA that you have to deal with. Depending on what kind of device it is, the process might be simple or it might take months. A lot of companies don’t realize this until they’re already halfway in.
That’s why knowing how medical device import licenses in Thailand work is such a big deal—because one small error can slow everything down. Let us understand about it in detail:
Thailand Medical Device Import License Regulations
Bringing medical devices into Thailand involves more than just paperwork — it’s about meeting the standards set by the Thai FDA. This section explains what rules apply, and what you need to legally import devices into Thailand.
Medical Device Classification In Thailand
Medical device regulations in Thailand divide products into four risk-based classes — from Class 1 (low risk) to Class 4 (high risk). Each class has its own level of regulatory scrutiny, including requirements for quality certification, safety data, and documentation.
Also Read: Medical Device Registration Process in Thailand
Import License For Medical Devices In Thailand
To sell a medical device in Thailand, the importer must hold a valid license tied to a registered establishment. This process checks that both the product and importer meet Thai FDA rules.
Preparing for Importation of Medical Devices In Thailand
Authorized Representative: Identify an authorized representative within Thailand. This representative serves as a vital link between the foreign manufacturer and the Thai FDA, facilitating communication and ensuring compliance with local regulations.
Local Presence: Establish a local presence and address in Thailand. All medical devices require a physical office within the country. In case the company doesn’t have a local presence, they can work with a Local Representative Company or Distributor.
Documentation and Technical Requirements:
- Gather comprehensive technical documentation, including design, manufacturing details, and safety information.
- Utilize the Global Medical Device Nomenclature (GMDN) system for traceability and patient safety.
- Adhere to labeling and packaging regulations set by the Thai FDA.
Medical Device Import Licenses Application Process
Submit an Importation Application:
Facilitate this process through the authorized representative.
Provide detailed device specifications, clinical evidence, and labeling information.
Quality system inspection may be required, especially for specific devices.
Review and Approval:
The Thai FDA conducts rigorous reviews for safety, effectiveness, and compliance.
Additional information or clarifications may be requested for comprehensive evaluation.
The review timeline varies based on device complexity and submitted documentation.
FDA Registration Certificate:
Successful review results in the issuance of an FDA registration certificate.
This certificate signifies compliance and allows lawful importation and distribution.
It is a critical document highlighting regulatory approval and legitimacy.
Compliance and Post-Importation
Maintain Adherence to Thai FDA Standards:
Ensure compliance with labeling and packaging requirements.
Regularly update labeling as needed.
Post-Market Surveillance:
Establish robust post-market surveillance for device performance and safety.
Promptly address any potential safety concerns based on user feedback.
Also Read: Pharma Products Registration Process in Thailand
Conclusion:
Successfully importing medical devices into Thailand takes more than paperwork—it requires local insight and timely coordination. Artixio supports this process end-to-end and can step in as your in-country representative through our Thai affiliate to keep things moving without delays.
