Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
EPSI GLOBAL PTE. LTD.
Singapore (HQ), Kuala Lumpur, Malaysia, Jakarta, Indonesia, Bangkok, Thailand, Hanoi, Vietnam, Manila, Philippines, Shanghai, China
We provide end-to-end regulatory solutions covering all classes of medical devices and IVDs in major APAC markets, especially the ASEAN region (Singapore, Malaysia, Indonesia, Thailand, Vietnam, Philippines) and major Northeast Asian markets (China, Korea, Japan). Services include classification, registration, local authorized representation, quality management system (QMS) implementation/auditing (ISO 13485/local GMP), and post-market surveillance. Their local presence minimizes market entry risks and time-to-market.
January 1, 2025
Approximately 5 minutes
Thailand IVD Device Registration: Classification, CSDT, and Local Requirements
Thailand IVD Device Registration and Approval
The regulation of In-Vitro Diagnostic (IVD) devices in Thailand falls under the Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (TFDA). The rules are established by the Medical Device Act B.E. 2562 (2019) and are harmonized with the regional ASEAN Medical Device Directive (AMDD).
⚙️ IVD Classification and Approval Routes
IVD devices are classified into four risk categories (1 through 4), based on factors like the intended purpose, expertise of the user, and public health impact. This risk classification determines the required approval route:
| Risk Class | Approval Route | Documentation Requirement | Est. Review Time (Max Standard) |
|---|---|---|---|
| Class 1 (Low) | Listing | Limited Documentation | 200 days |
| Class 2 & 3 | Notification | CSDT Full Format | 250 days |
| Class 4 (Highest) | License | CSDT Full Format | 300 days |
Note: All IVD registrations are valid for five years.
📝 Submission Requirements (CSDT)
For Class 2, 3, and 4 IVDs, the application must be submitted using the Common Submission Dossier Template (CSDT) Full format. Key components of the CSDT include:
- Executive Summary, Device Description, and Intended Use.
- Essential Principles of Safety and Performance and conformity documentation.
- Summary of Design Verification and Validation.
- Risk Analysis and Labeling Details.
- Quality Management Certification (ISO 13485) is required for Class 2-4 devices.
🧪 Special Cases and Testing Requirements
Specific high-risk IVDs may be subject to additional local requirements:
- In-Country Testing: Some high-risk IVDs may require in-country testing as determined by the TFDA on a case-by-case basis.
- Specific IVD Kits: Currently, HIV test kits and COVID-19 test kits and their reagents require performance test certificates issued by a local laboratory in Thailand.
🏦 License Holder Requirements
Similar to other medical devices, the IVD Import License is issued to a local, licensed company in Thailand.
- This local entity acts as the License Holder, owns and controls the license, and is required to have an Establishment License issued by the Thai FDA.
- The License Holder is integral to the importing process. While licenses cannot currently be transferred between holders, foreign manufacturers can designate multiple license holders for the same device at the same time.
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Approximately 5 minutes
Thailand Medical Device Registration and Approval: Compliance with Thai FDA and AMDD
Thailand's regulatory process, overseen by the Thai FDA's MDCD, follows the Medical Device Act B.E. 2562 (2019) and aligns closely with the ASEAN Medical Device Directive (AMDD). Devices are classified into four risk categories (1-4) and require one of three approval routes: Listing, Notification, or License.
Approximately 5 minutes
Thailand Medical Device Classification: Risk Categories and Thai FDA Verification
Medical devices in Thailand are classified into four risk categories (Class 1-4) based on intended use, invasiveness, and risk, closely following ASEAN MDD rules. Manufacturers can formally confirm their device classification by submitting an online application to the Thai FDA.
Approximately 5 minutes
Thailand Medical Device Grouping Rules: Simplifying Registration and Saving Costs
Thailand's new grouping guidance simplifies the registration process, allowing multiple products to be included in a single submission. Devices must share a product owner, intended purpose, and proprietary name, and can be grouped as a Single device, Family, System, Set, IVD Test Kit, or IVD Cluster, subject to specific variant rules.
Approximately 5 minutes
Thailand Medical Device Local Labeling Requirements: Language, Content, and Post-Import Affixing
Thailand's labeling rules, detailed in Ministry of Public Health Notification 137, require all home-use devices to be labeled in Thai. Devices used only by physicians can use Thai or English. The importer can affix the required labeling, including essential product and manufacturer details, within 180 days of the device entering the country.
Approximately 5 minutes
Thailand Medical Device Advertising Approval: Rules for DTC and HCP Communication
The Thai FDA regulates medical device advertising based on the target audience. Direct-to-Consumer (DTC) ads require prior approval, while advertisements targeted solely at Healthcare Professionals (HCPs) are generally exempt, provided they are not visible to the public. Approval licenses are valid for up to 3 years.
Approximately 5 minutes
Thailand Medical Device Post-Market Surveillance (PMS) and Adverse Event Reporting
The Thai FDA requires device defects and Adverse Events (AEs) occurring globally to be reported if the product is on the Thai market, following AMDD Annex 5 guidelines. The local Registration Holder is responsible for submitting reports and maintaining distribution/complaint records for at least five years.
Approximately 5 minutes
The Role of the Medical Device Control Division (MDCD) within the Thailand Food and Drug Administration (TFDA)
The TFDA is the national regulatory body in Thailand, with the Medical Device Control Division (MDCD) responsible for enforcing the Medical Device Act B.E. 2562 (2019). The MDCD oversees pre-market evaluation, registration, and post-market monitoring, ensuring medical devices comply with safety and quality standards aligned with the ASEAN MDD.