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Following the Ministry of Public Health Notification B.E. 2562 (2019) regarding alcohol-containing products intended for disinfection of humans, animals, and medical devices, the Medical Device Control Division has undertaken a comprehensive review of such products. This review included the issuance of notification certificates and the evaluation of supporting documentation required for regulatory submissions. To ensure

To mitigate the impact of the crisis situation in the Middle East and support manufacturers and importers of medical devices affected by disruptions in the supply chain of raw materials, packaging, or finished products, the Thai FDA has introduced a Fast Track channel for specific medical device change submissions. This initiative aims to facilitate faster

The Thai Food and Drug Administration (FDA) has announced updates to the establishment registration form for the manufacturing, import, and sale of medical devices. This revision enhances regulatory oversight in line with the digital age, aiming to cover new technologies, particularly Standalone Medical Software, while reducing bureaucratic steps for entrepreneurs and ensuring consumers receive clear,

In cases where identity verification cannot be completed via the Thai ID application as required by the system, the authorizer or the authorized person may instead use the document-based identity verification method. Power of Attorney (POA) to the Thai FDA is to formally authorize a representative, often a local agent or authorized person, to act

The Thai FDA has issued guidelines for the registration of patient-specific dental medical devices under Risk Classification 2–4. The key consideration is that product properties are assessed based on the primary raw materials rather than the finished product. Read the full infographic here: กองควบคุมเครื่องมือแพทย์  (Thai FDA Official Website in Thai). Purpose of the Guideline To

In accordance with the new Thai FDA Change Notification guidelines, the Thai FDA has revised the amendment timeframes within the Change Notification System. The updated requirement applies to newly submitted Change Notification applications starting from 20 April 2026. Read the full press release here: กองควบคุมเครื่องมือแพทย์ (Thai FDA Official Website in Thai). Purpose of the Press

The Ministry of Public Health has issued a new Announcement to update and modernize the requirements for record keeping and regulatory reporting related to the manufacture, importation, and sale of medical devices in Thailand under the Medical Device Act B.E. 2551 (2008), as amended. The objective of this Announcement is to strengthen regulatory oversight, ensure

The secretary of the Food and Drug Administration has issued a new Announcement to regulate the management, declaration, and reporting of remaining quantities and storage facilities of medical devices following: Business termination Non-renewal or refusal of renewal of Business establishment license, medical device licenses, notified certificates and listed certificates This announcement repeals and replaces the

The Ministry of Public Health has issued a draft Notification to revise and replace the existing regulation on the use of medical devices in clinical investigations (B.E. 2545 (2002). The proposed revision aims to modernize Thailand’s clinical investigation framework and align with current international standards. Read the full draft here: กองควบคุมเครื่องมือแพทย์ Purpose of the Draft