Entering the Thai Healthcare Market
Starts With the Right Local Partner
We register medical devices with the Thai FDA, all classes, Class 1 through Class 4. For foreign manufacturers who do not want to form a Thai company, DeeMED acts as your licensed local establishment and registration holder. Bangkok-based, with 15+ years Thai FDA regulatory experience on team.
What We Do
Local Authorized Representative & Importer of Record
You cannot legally import, sell, or register a medical device in Thailand without a TFDA-licensed local establishment acting as your representative. DeeMED holds a Thai FDA Medical Establishment License and acts as your official Local Authorized Representative and registration holder, submitting applications, managing compliance obligations, and serving as your legal point of contact with the Thai FDA. We also manage the physical import of your products, handling customs clearance and delivery to your Thai distributor, so your products enter Thailand legally and without disruption.
Product Classification & Regulatory Strategy
An incorrectly classified product can lose months in reclassification requests before a single submission is made. DeeMED assesses your device against TFDA classification guidelines (Class 1 through Class 4) and builds a regulatory strategy tailored to your product type, risk level, and existing international approvals, so the most efficient pathway to approval is identified from day one.
Reliance Route & Expedited Registration
If your device is already approved by the US FDA, EU Notified Bodies, TGA Australia, or Singapore HSA, you may not need a full TFDA review. Thailand's Reliance Route uses existing international approvals to significantly accelerate registration, reduce documentation requirements, and in eligible cases eliminate specialist review entirely. DeeMED actively uses this pathway wherever available to get your products to market faster.
CSDT Dossier Preparation & Submission
An incomplete or incorrectly structured CSDT is the single most common cause of registration delays in Thailand. DeeMED prepares complete, accurate Common Submission Dossier Template documentation: 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.
Medical Device Registration: Class 1 to 4
Registration timelines in Thailand vary significantly by class. Class 1 devices can be listed within days under the right conditions. Class 2 and 3 notifications and Class 4 licensing require precision documentation and proactive authority communication. DeeMED manages the full registration process for all device classes, handling government fees, authority correspondence, clarification responses, and approval tracking throughout.
IVD Registration
IVDs are subject to the same four-tier classification system as medical devices in Thailand, with specific technical documentation and laboratory testing requirements that differ from standard devices. DeeMED provides full registration support for IVDs across all classes, with direct experience in the documentation standards applicable to diagnostic products.
Biologics & ATMPs
Biologics and ATMPs represent the most complex and high-value regulatory pathways in Thailand, with longer timelines, more extensive documentation, and closer regulatory scrutiny than standard medical devices. DeeMED provides full regulatory strategy, dossier preparation, and authority liaison for biologics and ATMP developers seeking Thai market access, with our team's 15+ years of Thai FDA experience directly relevant to these pathways.
Cosmetics Notification & Registration
Every cosmetic product sold or imported in Thailand must be notified or registered with the TFDA before it enters the market. No exceptions.. DeeMED supports foreign cosmetics brands 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.
Post-Market Surveillance & Ongoing Compliance
A registration approval is not the end of your compliance obligations. It is the beginning of them. DeeMED supports clients with post-market surveillance, adverse event reporting, vigilance reporting to the TFDA, license renewals, and post-approval variations, maintaining ongoing regulatory monitoring to keep your products compliant and your licenses current throughout their validity period.
From Our Insights