• 2026-04-28 02:04:20

The FDA has opened "Fast Track" channel for changes notifications for manufacturers of essential medical devices who face unavoidable supply chain disruptions in raw materials and packaging materials.
These changes notifications can be reviewed more rapidly by officials than standard change notification, to support manufacturers during the crisis.

• 2025-02-20 11:17:07

From January 4, 2025, onwards, Thai FDA has tightened medical device advertising rules to prevent misleading claims. Advertisements must align with approved product information, specify target audiences, and include required disclaimers. Stricter enforcement measures target misleads advertising, especially for dermal fillers. Likewise Consumers shall verify approved products on the Thai FDA's website, updated on a weekly bases.

• 2025-02-20 11:06:06

The Thai FDA has launched a priority track for 6 types of medical devices targeting Non-Communicable Diseases (NCDs), enabling faster approval for essential healthcare solutions. This initiative is designed to ensure quicker access to vital healthcare solutions, providing medical device companies with faster market entry for devices targeting public health challenges.

• 2025-02-20 10:48:19

In 2025, the Thai FDA reinstated the auto approval system for specific Class 1 medical devices with additional conditions. The new "Positive List" identifies eligible devices by their GMDN generic names, expediting approvals while others require manual review.

• 2024-09-17 02:22:43

The Thai FDA has announced significant regulatory changes to accelerate the approval process for medical device manufacturing and importation. Effective June 6, 2024, these changes aim to reduce redundancy in documentation without compromising product safety or quality. This streamlined approach is expected to foster innovation, attract foreign investment, and enhance Thailand's position as a regional healthcare hub.

• 2024-05-07 08:47:38

Thai FDA has replaced its previous criteria for evaluating medical devices via expedited routes with new guidelines published in 2024. The aim is to streamline the evaluation process for Licensed and Notified medical devices (Class 2,3,4) while ensuring quality, efficiency, and safety. The announcement outlines criteria, documents required, and regulatory procedures for the Concise Evaluation and Reliance Program routes under expedited route review.

• 2024-04-03 09:01:31

Enforced from January 5, 2025, the official gazetting of the 'Good Criteria and Practice for Importing and Selling of Medical Devices 2023', marks a significant milestone in Thailand's medical device regulations.

• 2023-03-27 08:27:31

Thai FDA announces 'Thailand FDA - WHO Collaborative Registration Procedure (CRP) for in vitro diagnostics (IVDs)', an expedited medical device registration program aimed at reducing the time required for manufacturers and importers to register their products. The program officially commenced on December 28, 2022, onward.

• 2022-12-27 05:30:57

To promote an effective reviewing procedure, Thai FDA granted that therapeutic medical devices shall be classified and registered under Listing (Class 1 medical device), in effect from 3rd December 2022 onward.

• 2021-09-29 00:18:14

Thailand’s Ministry of Public Health has recently approved the import permit exemption of 24 additional Sars-CoV-2 (COVID-19) related Medical Device(s), for donation purposes.