Registering a medical device in Thailand is a mandatory legal requirement governed by the Thai Food and Drug Administration (FDA). It ensures that all medical devices meet the safety, quality, and efficacy standards set by the government under the Medical Device Act B.E. 2551. Without registration and securing necessary approvals, you cannot legally market or distribute your products in Thailand.
In this article, we will walk you through the key requirements, medical device classifications, and process of how to register a medical device in Thailand.
Regulatory Update (June 2026): Thailand's Medical Device Labeling Regulation (B.E. 2568), published in the Royal Gazette on December 22, 2025, is now in effect. Mandatory compliance is required by June 20, 2026. This regulation establishes clearer requirements for labels and accompanying documents (instructions for use), aligned with the Medical Device Act B.E. 2551 and its amendments. Manufacturers and importers should review their current labeling against the new framework before this deadline.
Key Pre-requisites Before Medical Registration in Thailand
Under the 2019 Amendment (No. 2) of the Medical Device Act, all regulatory interactions must be done through the SKYNET e-submission portal. This centralized platform serves as the legal interface between your business and the Medical Device Control Division (MDCD).
Before you start the medical device registration process, you must establish the right infrastructure in Thailand. This includes local representation, correct licenses, and understanding the medical device classification system.
1. Appointing a Local Representative
To register a medical device in Thailand, you need to have a legally registered Thai Entity or a Local Representative to act as your “License Holder”. The Medical Device Act explicitly mandates that only a locally registered company can apply for and hold an Establishment License for importing or manufacturing medical devices. This entity takes full legal responsibility for the device's safety and quality in Thailand.
Emerhub can act as your local agent in Thailand as your Importer of Record. We have all the necessary Establishment Licenses needed to start your medical device registration process.
Alternative: We can also help set up your own company in Thailand to hold all the licenses associated with registering your medical products. With a Thai company, you have full control of your own entity, switch distributors, and protect your proprietary technical dossiers. However, you need to register your business with the Department of Business Development (DBD) and fulfil requirements such as minimum paid-up capital and a local office.
2. Securing an Establishment License
Through your own legal entity in Thailand or with a local agent, you need to have the correct Establishment License to register a medical device. This ensures that you or your representative has the capability to handle medical equipment in Thailand. The Thai FDA issues two types:
- FDA Import License (Form Orr. 7): License to import medical devices from overseas into Thailand. Requires you to prove you have the logistical capacity to maintain the quality of imported goods from the moment they arrive at the port of entry.
- Manufacturing License (Form Orr. 2): Required for entities who manufacture medical products in Thailand. You must demonstrate that your factory adheres to strict environmental and safety controls. This ensures that every medical device unit produced is consistent with the technical specifications approved by the FDA during registration.
Important: The Thai FDA requires proof that the manufacturing site follows international quality standards. A valid ISO 13485 certificate is non-negotiable for the actual factory where the device is produced. If your product is manufactured by an Original Equipment Manufacturer (OEM), the OEM's certificate must be provided. Without this, the FDA will not recognize the quality of the device, regardless of its performance in other markets.
3. Determine the Classification of your Medical Device
Thailand follows a four-tier risk-based classification for medical devices under the Association of Southeast Asian Nations (ASEAN) Medical Device Directives (AMDD). Each classification has its specific regulatory requirements, documentation, fees, and review process.
| Risk Level | Registration Pathway | Examples |
|---|---|---|
| Class 1 (Low Risk) | Listing (Simple) | Examination gloves, body fat analyzers, hospital beds, wheelchairs. |
| Class 2 (Low-Moderate) | Notification (Standard) | Ultrasound gel, surgical masks, sterile gauze, syringes. |
| Class 3 (Moderate-High) | Notification (Standard) | Contact lenses, hemodialysis machines, ophthalmic viscoelastics. |
| Class 4 (High Risk) | Licensing (Full) | Pacemakers, coronary stents, breast implants, HIV test kits. |
The classification of your medical device will determine the specific registration process that you need to follow with the Thai FDA. Below you will find an overview of the different registration processes:
- Listing: Class 1 medical devices require a Certificate of Listed Medical Devices. The document requirements are generally lower as similar devices are already registered and listed.
- Notification: For classes 2 and 3, you must provide more data regarding the devices and obtain a Certificate of Notified Medical Devices. Typically this is the process for new manufacturers or a registered manufacturer of the same parent company entering the market.
- Licensing: More resource intensive as it concerns high-risk class 4 devices, such as vaccines and experimental treatments. The Thai FDA will typically conduct a thorough evaluation and due diligence check before registration.
Thailand Medical Device Registration Requirements
Because medical devices can impact public health and safety, foreign manufacturers are required to submit a thorough overview of the product for FDA approval. It is important to consider that manufacturing regulations may differ in Thailand compared to other countries.
The following data is required to be submitted in English with the medical device registration application in Thailand:
- Common Submission Dossier Template (CSDT) demonstrating the safety, performance, and quality of the medical device.
- Detailed overview, intended use, packaging, and user guidance must be provided.
- Pre-clinical and clinical data supporting safety and performance.
- Documentation demonstrating risk management and compliance with safety principles.
- ISO 13485 certification or equivalent proof of quality system compliance.
- Information about manufacturing processes and formal declarations confirming conformity to standards (Declaration of Conformity).
- Certificate of Free Sale or Certificate of Origin from the country of manufacture is required.
- Existing regulatory approvals or market authorizations
In June 2024, the Thai FDA introduced an Abridged Pathway for devices with at least one year of approval from recognized agencies (e.g., US FDA, EU Notified Bodies, TGA). This pathway reduces documentation requirements by exempting some documents like risk analysis, manufacturer info, and design validation if the device matches previously approved versions in use, labeling, and packaging. The Full Pathway remains for other devices, requiring complete documentation including all risk and design data.
Medical Device Labeling Standards in Thailand
In December 2025, Thailand's Medical Device Labeling Regulation (B.E. 2568) was published in the Royal Gazette, establishing binding requirements for labels and Instructions for Use (IFU). Compliance is mandatory by June 20, 2026. This regulation supersedes and consolidates earlier labeling notifications under the Medical Device Act B.E. 2551.
Manufacturers and importers should review their current labeling against the requirements below before the deadline, as non-compliant labeling can delay registration or trigger a compliance review.
Language Requirements
The distinction between home-use and professional-use devices is now formally codified under the regulation:
- Home-use devices must have labels and IFUs strictly in Thai to protect non-expert users.
- Professional-use devices may use Thai or English, provided the labeling is clear and accessible to clinical personnel. Additional languages are permitted as long as they do not contradict the primary language.
Required Label Content
Labels must be clearly visible and legible on the device or its packaging. The following must be included where applicable:
- Trade name and intended use
- Batch, serial number, and UDI code (where applicable)
- Name and address of the manufacturer and local importer
- Manufacturing date and expiration date (in YYYY format), or post-opening stability period where relevant
- Warnings, contraindications, and precautions for use
- Storage conditions and validated sterilization procedures (where applicable)
- License or registration number
Special Labeling Requirements
- Reusable devices (including surgical and dental instruments): For reusable devices, the regulation introduces more detailed requirements than previously mandated. Labels must clearly indicate:
- The number of validated sterilization cycles
- Storage conditions
- Post-opening shelf life, where applicable
- The number of validated sterilization cycles
- Storage conditions
- Post-opening shelf life, where applicable
- Software-based medical devices (SaMD): Electronic labeling in Thai or English is required, and must include version number, warnings, and UDI where applicable.
- Digitalization: QR Codes and Electronic IFUs: B.E. 2568 formally authorizes the use of QR codes and electronic Instructions for Use (e-IFUs), particularly for software and connected devices. Key requirements include:
- Digital information must be synchronized with physical documentation and updated in parallel with any registration changes
- Information must remain accessible offline to ensure continuity in all clinical settings
- For certain high-risk devices, the Thai FDA may still require a paper IFU but is evaluated on a case-by-case basis.
- Digital information must be synchronized with physical documentation and updated in parallel with any registration changes
- Information must remain accessible offline to ensure continuity in all clinical settings
- For certain high-risk devices, the Thai FDA may still require a paper IFU but is evaluated on a case-by-case basis.
120-day post-import labeling requirement: Once a license is obtained, importers have a mandatory 120-day window to complete compliant labeling in Thailand. This includes language management, QR codes, and final label layout. Exceeding this deadline risks a distribution block in the Thai market, with potential repercussions on supply timelines.
If you are registering a medical device or managing an existing license, ensure all labeling documentation submitted via SKYNET reflects the updated B.E. 2568 requirements.
Non-compliant labeling may result in clarification requests, delays, or rejection. If your device is already registered and labeling changes are needed to meet compliance, assess whether those changes constitute an amendment based on your device's classification. This is critical since incorrect categorization of amendments can affect your license status.
How to Register a Medical Device in Thailand
Medical device registration in Thailand can take 1-2 months for Class 1 devices, and up to 4 - 14 months for Class 2 and higher. Because these products affect the safety and well-being of the public, the Thai FDA is strict and rigorous when it comes to evaluating your goods.
Step 1: Preparation and Pre-registration
To start the process, you need to make sure all key requirements above are met. This includes appointing a LAR or setting up your own Thai company to hold all the licenses. You or your agent must have the correct Establishment License, whether you plan to import your goods from overseas or manufacture them in Thailand.
Part of the preparation is to also determine the classification of your products. This will determine the level of scrutiny and requirements needed for your registration. Our local agents can assist you in determining the right classification during the initial stages of the registration process.
Step 2: Compile a CSDT Dossier (For Class 2 or Higher)
For Classes 2, 3, and 4, the Common Submission Dossier Template (CSDT) serves as the technical documentation to prove safety and performance of your product. This format ensures that the Thai FDA receives a standardized set of evidence to evaluate the safety, quality, and performance of your device.
Here are the core components of a CSDT:
- Executive Summary: Provide a concise "Benefit-Risk" ratio, a clear intended use statement, and a comprehensive regulatory history. If the device has been subject to recalls or adverse events in other markets, these must be disclosed and addressed here with corrective action data.
- Device Description and Specification: Requires high-resolution engineering drawings, a full bill of materials. This includes chemical compositions for all patient-contacting parts (critical for biocompatibility review) and functional specifications that explain the mechanism of action.
- Manufacturing and QMS Information: provide flowcharts of the production process, environmental controls for sterile products, and site-specific Quality Management System (QMS) data that proves the factory address matches your ISO 13485 certification exactly.
- Risk Management Reports: A detailed analysis following ISO 14971, identifying potential hazards associated with the device's use and the specific mitigations implemented during the design phase.
Step 3: Submission via SKYNET
The formal application starts when you submit all the needed documents to the SKYNET e-Submission platform. Depending on your device’s class, you would need to pay the following fees:
| Risk Class | Submission Fee | Specialist Review Fee | Approval Fee | Total (Approx) | Est. Approval Time |
|---|---|---|---|---|---|
| Class 1 (Listing) | 500 THB | N/A | 2,000 THB | 2,500 THB | 1 - 5 Days (auto approved) |
| Class 2 (Notification) | 1,000 THB | 38,000 THB* | 10,000 THB | 49,000 THB | 4 - 8 Months |
| Class 3 (Notification) | 1,000 THB | 38,000 THB* | 10,000 THB | 49,000 THB | 4 - 8 Months |
| Class 4 (Licensing) | 1,000 THB | 53,000 THB* | 20,000 THB | 74,000 THB | 10 - 14 Months |
During this phase, the Thai FDA will review the completeness of your documents and conduct a technical review of your product. Qualified applications will proceed to a substantive review. This includes document verification for specs, risk analysis (ISO 14971), clinical data summaries, and quality systems (ISO 13485). Higher classes (3-4) may involve a Conformity Assessment Body (CAB) for independent audits on design, performance, and GMP.
Reviewers frequently issue "Clarification Requests" regarding clinical evidence, sterilization validation, or risk mitigations. During this step, our experts can help you liaise with the Thai FDA to help streamline the process.
Step 4: Receive your Final Approval
Once your application is approved, you will receive the official Registration Certificate digitally. These approvals confirm compliance with safety, quality, and performance standards, allowing legal import, sale, and distribution. They are typically valid for 4-5 years, depending on the class and issuance date.
As your representative in Thailand, Emerhub will handle the registration process of your medical device from the preparation phase to approval. We can also manage your renewal process after the 5-year licensing period. Keep in mind that the specific renewal fees can vary depending on the classification and type of device that you are planning to market within Thailand.
Want to register a medical device in Thailand? Contact us via the form below to get in touch with one of our local experts!
Frequently asked questions
Are clinical data required for all device classes?
Clinical data are generally required for higher-risk medical devices to demonstrate safety and performance, but not usually mandatory for Class 1 (low-risk) devices. For Classes 2 and 3 (Notification) and Class 4 (License), submission of clinical evaluation or clinical data is expected as part of the CSDT to support the device’s safety and effectiveness.
Can foreign manufacturers register devices directly?
Foreign manufacturers cannot register medical devices directly in Thailand. According to Thai regulations, only Thai nationals or locally established companies holding a valid Establishment License can apply for medical device registration with the Thai FDA. Foreign manufacturers must therefore: The LAR acts as the official regulatory liaison, submitting applications and managing compliance with the Thai FDA. This framework ensures that device registration and importation are controlled by entities with a local presence and accountability.
How long is a medical device registration valid in Thailand?
Medical device registration in Thailand is generally valid for 5 years for Class 1 devices, while for Classes 2, 3, and 4, the validity is typically 4 years according to recent regulatory updates.
What are common reasons for registration delays or rejection?
Common reasons for medical device registration delays or rejection in Thailand include: If rejected, the applicant receives a notice detailing reasons and may resubmit with corrections or appeal.