Thailand FDA Medical Device Registration & Thai License Holder
Enter ASEAN's second largest medtech market, importing over 80% of its devices and powered by universal healthcare, world class medical tourism, and a fast aging population. NexorTest delivers end-to-end Thai FDA registration: Class 1/2/3/4 & IVD licensing, CSDT dossiers, SKYNET e-submission, the Abridged & Reliance fast tracks, independent Thai License Holder representation, and SaMD/AI compliance all under one expert roof.
Four Risk Based Device Classes Under Thailand's Medical Device Act
The Thai FDA classifies all medical devices and IVDs into four risk classes under the ASEAN Medical Device Directive (AMDD) based on intended use, invasiveness, and duration of body contact. Your class sets the route, the CSDT documentation, fees, and review timeline.
Class 1 Listing Route
Low risk devices such as bandages, examination gloves, dental mirrors, electrodes, and eye patches. Devices on Certain Class 1 devices included in the Thai FDA Positive List may qualify for simplified electronic registration through SKYNET since Jan 2025.
- Positive List
- Auto Approval
- Days to Weeks
Class 2 Devices
Low to moderate risk devices such as syringes, suction equipment, and hypodermic needles. Notification route with a full CSDT dossier and ISO 13485 evidence required.
- Notification
- CSDT Required
- ISO 13485
Class 3 Devices
Moderate to high risk devices including blood pressure monitors, infusion pumps, ventilators, and many electro medical and software devices. Notification route with full CSDT and possible Specialist Review.
- Notification
- 250 Working Days
- Specialist Review
Class 4 & Licensing
Highest-risk devices such as implantables, cardiovascular devices, and critical IVDs for HIV, HBV, and HCV. Licensing route with a complete CSDT and full Thai FDA review; some IVDs need local testing.
- Licensing
- ~300 Working Days
- Clinical Evidence
Choosing the Fastest Route to Your Thai FDA License
Thailand offers full, abridged, and reliance pathways. Picking the right route based on your existing approvals and dossier readiness can cut months off your SKYNET review timeline.
Singapore HSA Reliance
Leverage a Singapore HSA approval with an identical CSDT dossier and written consent to share documentation. The application bypasses the Specialist Review step saving the and 1-3 months of review time the fastest route for HSA cleared devices.
Reference Agency Abridged
For devices approved 1+ year by the US FDA, an EU Notified Body, TGA, MHLW, Health Canada, or WHO Prequalification. Selected CSDT documents including risk analysis and design verification and validation are waived where trade name, intended use, labeling, and packaging are unchanged.
Standard Full CSDT
For novel devices or those without qualifying reference approval, a complete CSDT in Full format is submitted for full Thai FDA review. We design the clinical and performance evidence strategy and manage Specialist Review queries to keep the review on track.
Comprehensive Thailand Regulatory Services
From classification and Thai License Holder representation through post-market vigilance, NexorTest manages every aspect of your Thai FDA regulatory journey.
Thai FDA Product Registration
Complete medical device licensing for Class 1, 2, 3, and 4 devices and IVDs Listing, Notification, or Licensing. We manage classification, CSDT preparation, SKYNET submission, fee payment, and query resolution end to end.
CSDT Dossier Preparation
End-to-end ASEAN Common Submission Dossier Template authoring device description, risk analysis, design verification and validation, ISO 13485 mapping, and clinical or performance evidence formatted to AMDD and Thai-specific requirements.
Abridged & Reliance Fast-Track
For devices approved abroad, we run the Abridged pathway (US FDA, EU, TGA, MHLW, Health Canada, WHO PQ) or the Singapore HSA Reliance route waiving documents and bypassing Specialist Review to shorten your timeline.
Independent Thai License Holder
Independent Local Authorized Representative and Establishment License services. NexorTest holds your product license neutrally, applies for each LPI, manages all Thai FDA interactions, and lets you appoint or change distributors freely without losing control.
SKYNET e-Submission Management
We manage your OPEN ID, SKYNET FDA system access, and the entire pre-submission and e-submission workflow passing the 15 day completeness check and resolving every deficiency within the response window.
Thai Labeling, IFU & UDI
Thai-language labeling and IFU per the 2025 labeling Notification (effective June 2026), English where permitted for professional-use devices, plus readiness for the draft UDI requirements covering Class 2, 3, and 4 devices.
IVD Registration Thailand
In Vitro Diagnostic registration across all four AMDD classes. High risk IVDs (HIV, HBV, HCV) are Class 4 requiring full CSDT and possible local testing certain professional use Class 1 IVDs on the Positive List qualify for auto approval.
SaMD & AI/ML Devices
Software as a Medical Device and AI/ML strategy aligned with Thailand's revised establishment forms covering standalone software notification ahead of SaMD professional use annual reporting starting in 2027.
Vigilance, LPI, Changes & Renewals
Post-market vigilance and annual PMS reporting (by May 31), License Per Invoice management for each shipment, change notifications, and 5 year license renewals via SKYNET keeping your registration active and compliant throughout its lifecycle.
Thailand's Trusted Thai FDA Specialist
We combine an on the ground Bangkok regulatory team with global reliance expertise to deliver faster, more predictable Thai FDA approvals.
Bangkok Based Regulatory Team
Thai native specialists who know the Medical Device Control Division (MDCD), the SKYNET portal, and the AMDD classification rules first hand not an offshore desk learning the system from a distance.
Abridged & Reliance Specialists
We turn your US FDA, EU, or Singapore HSA approval into an Abridged or Reliance submission waiving CSDT documents and bypassing Specialist Review to cut months off your timeline.
Independent License Holder You Keep Control
We hold your registration as a neutral Local Authorized Representative, so you can switch or add distributors anytime and since June 2025 the CSDT fulfillment system allows transfers without restarting.
One Partner for ASEAN & Global Access
Coordinate Thailand alongside Singapore HSA, Malaysia MDA, US FDA, EU MDR/CE, and Japan PMDA from a single integrated program ideal for a reliance cascade across Southeast Asia.
Transparent Fixed Fee Packages
Our fixed fee scopes cover classification, CSDT, License Holder, SKYNET submission, and post-market support, with clear milestones the predictability incumbents rarely offer.
Six Steps to Your Thai FDA License
A proven, structured approach that minimizes SKYNET deficiencies and accelerates your path to a 5 year Thai FDA license.
Classification & Pathway Strategy
We confirm your AMDD risk class (1, 2, 3, or 4), set the route Listing, Notification, or Licensing and identify whether you qualify for the Abridged or Reliance fast track based on existing approvals.
Appoint Thai License Holder
NexorTest is appointed as your independent Thai License Holder, holding a valid Establishment License and ready to hold your registration and submit through SKYNET on your behalf.
CSDT Dossier Preparation
We compile the Common Submission Dossier Template device description, risk analysis, design verification and validation, ISO 13485 evidence, and clinical or performance data applying Abridged or Reliance reductions where eligible.
Legalization & Thai Translation
We legalize the Certificate of Free Sale and Letter of Authorization and translate labeling and IFU into Thai for home-use devices, with English accepted for professional-use technical content.
SKYNET Submission & Query Management
We submit through the SKYNET e-submission portal, pay government fees, pass the 15 day completeness check, and manage every deficiency response and Specialist Review query to keep the review on track.
License, LPI, UDI & Post-Market
You receive your 5 year license. We obtain the License Per Invoice for each shipment, prepare you for UDI on Class 2-4 devices, file annual PMS reports, and manage changes and renewals before expiry.
Thai FDA Expertise Across Every Device Category
From implantables to AI driven digital health, our regulatory specialists cover the full breadth of medical technology entering the Thailand market.
- 🫀 Cardiovascular & Implants
- 🧬 In Vitro Diagnostics
- 🤖 AI/ML & CADe/CADx
- 💻 SaMD & Digital Health
- 🩻 Imaging & Radiology
- 🦴 Orthopaedics
- 💉 Infusion & Drug Delivery
- 🩸 Surgical Instruments
- 👁 Ophthalmics
- 🦷 Dental Devices
- 🏥 Electro-Medical Equipment
- 📱 Wearables & Remote Monitoring
Frequently Asked Questions for FDA Medical Device Registration Thai
What is Thai FDA medical device registration?
Thai FDA registration is the mandatory market authorization issued by the Medical Device Control Division (MDCD) of the Thai Food and Drug Administration, under the Ministry of Public Health. Under the Medical Device Act B.E. 2551 (2008), as amended in 2019, every device and IVD must be Listed, Notified, or Licensed before import or sale. The framework follows the ASEAN Medical Device Directive (AMDD) with four risk classes (1-4). The process covers classification, appointment of a Thai License Holder with an Establishment License, a CSDT dossier, and submission via the SKYNET portal. Licenses are valid for 5 years.
Do I need a local License Holder to register?
Yes, Foreign manufacturers cannot register directly. Only a Thai national or a Thailand-based entity holding a valid Establishment License can apply and hold the registration. This Local Authorized Representative (LAR) / License Holder submits via SKYNET, holds the license, applies for the License Per Invoice (LPI) per shipment, pays fees, and handles renewals and vigilance. NexorTest provides independent License Holder services so you can switch distributors freely and since June 2025, the CSDT fulfillment system allows license transfers without restarting registration.
What is the CSDT and is it mandatory?
The Common Submission Dossier Template (CSDT) is the ASEAN harmonized technical file required by the Thai FDA covering device description, intended use, labeling and IFU, risk analysis, design verification and validation, ISO 13485 evidence, clinical or performance data, and Letters of Authorization. Full CSDT is mandatory for Class 2, 3, and 4 Class 1 Listing needs limited documentation. Thailand accepts Partial CSDT (Partial 1 or 2) in some cases, but full CSDT must be completed before renewal. NexorTest compiles and QC checks the entire CSDT before SKYNET submission.
What are the Abridged and Reliance fast tracks?
The Abridged pathway (2024) applies to devices approved 1+ year by a reference agency US FDA, EU Notified Body, TGA, MHLW, Health Canada, or WHO Prequalification waiving documents like risk analysis and design verification and validation when trade name, intended use, labeling, and packaging are unchanged. The Reliance route applies to Singapore HSA approved devices with an identical dossier and consent to share documentation, it bypasses Specialist Review (THB 53,000) and saves 1-3 months. A Thailand Malaysia MDA reliance pilot may expand options further.
How long does Thai FDA registration take?
Class 1 devices on the Positive List are auto approved within days via SKYNET (since Jan 2025) others take weeks to months. Class 2 and 3 (Notification) reviews run up to about 250 working days, and Class 4 (Licensing) up to about 300 working days, though actual times are often shorter. A 15 day completeness check precedes evaluation. The Abridged and Reliance routes can cut 1-3 months. Documentation completeness is the biggest timeline driver, so our pre-submission QC prevents costly deficiency cycles.
What documents are required for registration?
Required documents include a Letter of Authorization appointing the Thai License Holder; a legalized Certificate of Free Sale (CFS) from the country of origin an ISO 13485 certificate for the manufacturing site (mandatory for Class 2-4) the CSDT technical file with risk analysis, design verification and validation, and clinical or performance evidence; a Declaration of Conformity; and Thai language labeling and IFU for home use devices (English accepted for professional use). Wireless devices also need separate NBTC approval, and some products (high risk IVDs, gloves) may need local testing.
Does Thailand accept FDA/CE approval?
Prior approval from the US FDA, EU (CE under MDR), TGA, MHLW, Health Canada, Singapore HSA, or WHO Prequalification strongly supports a Thai application, but it does not grant automatic approval the Thai FDA always conducts its own review. The practical advantage is major a 1+ year approval from a recognized agency unlocks the Abridged pathway, and a Singapore HSA approval unlocks the Reliance route that bypasses Specialist Review. A Certificate of Free Sale also strengthens higher risk applications. We convert your existing approvals into the fastest viable Thailand pathway.
What is the cost of Thai FDA registration?
Costs combine government fees, professional fees, and License Holder fees. Government fees comprise an application fee, an approval fee, and an optional Specialist Review fee (THB 53,000) selected at TFDA discretion for novel technology or new indications. Renewal fees are around THB 10,000 for Notified (Class 2-3) and THB 20,000 for Licensed (Class 4) devices. Class 1 Listing is the most economical route, and Abridged registrations renew on immediate fee payment with no extra documents. Professional fees depend on class, pathway, and scope. NexorTest offers transparent fixed-fee packages contact us for a free cost assessment.
Ready to Enter the Thailand Medical Device Market?
Get a free Thai FDA regulatory assessment from specialists in Thailand market access. Our experts will map your fastest route including the Abridged and Singapore HSA Reliance pathways to a 5 year Thai FDA license.