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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.
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).
The TFDA has made many important regulatory updates within the last several years including:
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
Our Overview of the Medical Device Registration Page
Notifications/Announcements from the TFDA
Information on TFDA Medical Device Classification
List of Registered Certified Bodies
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.
US: +1 512 898-9222
SG: +65 3138-4148
EMAIL: India@asiaactual.com
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