Thailand’s Food and Drug Administration (TFDA)

The Thailand Food and Drug Administration (TFDA) is the national regulatory body and competent authority responsible for the registration, evaluation, and monitoring of food and drug products in Thailand. The agency is located in Nonthaburi and was established in 1979 under the Ministry of Public Health to ensure the protection of public health/consumer rights. It oversees the manufacturing, import, and distribution of regulated products to ensure that they comply with strict safety and quality standards.  

Thailand’s medical device registration is managed by the Medical Device Control Division (MDCD) of the TFDA. The MDCD was established in 1991 and is responsible for enforcing compliance with these medical device regulations and for taking action against any company or individual that fails to comply.  

The division evaluates the safety, quality, and efficacy of new medical devices before they are allowed to be sold in Thailand. This process includes pre-market evaluation, clinical trials, and post-market monitoring to ensure that the products are safe and effective. News updates from the organization can be found here. 

Recent History of the TFDA 

In recent years, the MDCD has undergone significant changes to modernize its regulatory framework and improve the safety and quality of medical devices in the country. The division has implemented measures to streamline the application process for new devices. 

In 2015, the Thai government ratified the ASEAN Medical Device Directive, (AMDD) which aimed to align regional regulatory standards and streamline the country’s medical device regulatory system. Additionally, the Thailand regulatory process is based on the Medical Device Act B.E. 2551 (2008) and was updated by the Medical Device Act/Ordinance B.E. 2562 (2019).  

Significant Recent TFDA Regulatory Updates    

The TFDA has made many important regulatory updates within the last several years including: 

1. Classification & technical documentation requirement updates, 
2. Specialist review for certain medical devices — details here,  
3. Required annual report submission from license holders — details here, 
4. Fast track for Class D devices from the Singapore medical device registry — details here.  

Recent Blogs on Thailand 

Thai FDA Issues Guidance on Specialist Review Selection Criteria 

Thailand FDA Provides Guidance on Classification of Physical Therapy Devices 

Thailand FDA Publishes Guidance for Software as Medical Device 

Thai FDA Fast Track Route for COVID Related Products to Stop 

How New EU MDR Requirements Will Affect Registrations in Asia 

More Information on TFDA Regulatory Requirements for Medical Devices 

Our Overview of the Medical Device Registration Page 

Notifications/Announcements from the TFDA 

Information on TFDA Medical Device Classification 

TFDA e-Submission Interface 

List of Registered Certified Bodies  

Come Grow with Us

Contact Asia Actual if you have any questions and/or would like to learn more about accessing the Thai market specific to your product portfolio.

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.