Bangkok-based
TFDA Medical Device Establishment Licensed
Expert Regulatory Guidance for Medical Devices, IVDs, Biologics, ATMPs, & Cosmetics
DeeMED supports international manufacturers and healthcare companies seeking to register, import, and distribute regulated products in Thailand. We work with medical device manufacturers, biotech and biologics companies, ATMP developers, and cosmetics brands from the United States, United Kingdom, Europe, China, Singapore, Hong Kong, South Korea, and beyond — guiding them through every stage of Thai FDA compliance and market entry.
Every foreign manufacturer entering the Thai market requires a Local Authorized Representative. As a TFDA-licensed establishment, DeeMED acts as your official LAR — submitting applications, managing compliance obligations, and serving as your legal point of contact with the Thai FDA. We also serve as Importer of Record, taking full responsibility for customs clearance, import licensing, and regulatory accountability so your products enter Thailand legally and without disruption.
Before any submission begins, correct product classification is critical. DeeMED assesses your device or product against TFDA classification guidelines — Class I through Class IV for medical devices and IVDs — and builds a regulatory strategy tailored to your product type, risk level, and existing international approvals. Getting this right from the start avoids costly delays and ensures the most efficient pathway to approval.
For medical devices already approved by recognized international authorities — including the US FDA, EU Notified Bodies, TGA Australia, or Singapore HSA — Thailand's Reliance Route offers a significantly faster registration pathway. DeeMED actively uses this route to accelerate approvals, reduce documentation requirements, and eliminate the need for specialist review in eligible cases. This is one of the most effective tools available for reducing time to market in Thailand.
For Class II, III, and IV medical devices and IVDs, the TFDA requires a full Common Submission Dossier Template. DeeMED prepares complete, accurate CSDT documentation — including technical files, safety and performance data, risk analysis, ISO 13485 evidence, labeling, and Thai language translations — and manages the full e-submission process through the TFDA portal. Complete and well-prepared documentation is the single most effective way to accelerate approval timelines.
DeeMED manages the full registration process for all medical device classes. Class I devices can be listed within days under the right conditions. Class II and III notifications and Class IV licensing are managed with precision documentation and proactive authority communication to minimize review time. We handle all government fees, authority correspondence, clarification responses, and approval tracking throughout the process.
In vitro diagnostic devices are subject to the same four-tier classification system as medical devices in Thailand. DeeMED provides full registration support for IVDs across all classes, with particular attention to the technical documentation requirements and laboratory testing standards applicable to diagnostic products.
Biologics and advanced therapy medicinal products represent some of the most complex and high-value regulatory pathways in Thailand. While these products require longer timelines and more extensive documentation than standard medical devices, DeeMED is experienced in navigating these pathways. We provide full regulatory strategy, dossier preparation, and authority liaison for biologics and ATMP developers seeking Thai market access.
Thailand requires all cosmetics to be notified or registered with the TFDA before they can be imported or sold. DeeMED supports foreign cosmetics brands and manufacturers with product notification, controlled and specially controlled cosmetics registration, labeling compliance, and Thai FDA liaison. Standard cosmetics notifications can be completed in as little as one week with correct documentation.
Registration is not the end of the compliance journey. DeeMED supports clients with post-market surveillance obligations, adverse event reporting, vigilance reporting to the TFDA, license renewals, and post-approval variations. We maintain ongoing regulatory monitoring to keep your products compliant and your licenses current throughout their validity period.
