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.
December 1, 2024
Approximately 5 minutes
Thailand Medical Device Registration and Approval: Compliance with Thai FDA and AMDD
Thailand Medical Device Registration and Approval
The regulatory process for medical devices in Thailand is administered by the Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (TFDA). The current framework is based on the Medical Device Act B.E. 2562 (2019) (Issue 2) and is designed to align with the regional ASEAN Medical Device Directive (AMDD).
⚙️ Risk Classification and Approval Routes
Medical devices in Thailand are classified into four risk categories (1 through 4), following the AMDD guidance:
| Risk Class | Approval Route | Max Review Time (Standard) | Submission Format | Validity |
|---|---|---|---|---|
| Class 1 (Low) | Listing | Auto-approved or 200 days | Limited Documentation | 5 Years |
| Class 2 (Low-Moderate) | Notification | 250 days | CSDT Full Format | 5 Years |
| Class 3 (Moderate-High) | Notification | 250 days | CSDT Full Format | 5 Years |
| Class 4 (High) | License | 300 days | CSDT Full Format | 5 Years |
Note: All licenses and registrations are valid for five years and require renewal.
📝 Application Requirements
All applications, except for Class 1 (Listing), require submission in the Common Submission Dossier Template (CSDT) Full format, which is a comprehensive set of documents including:
- Executive Summary
- Device Description and Intended Use
- Essential Principles of Safety and Performance and conformity evidence.
- Summary of Design Verification and Validation
- Risk Analysis
- Proof of Foreign Regulatory Approval
- Quality Management Certification (ISO 13485) is required for Class 2–4 devices.
🌐 Expedited Pathways
The Thai FDA offers two accelerated routes for market access:
- Reliance Route: Allows manufacturers to leverage existing marketing approvals issued by the Health Sciences Authority (HSA) in Singapore. This route is available for Class B, C, and D devices that meet specific documentation criteria (CSDT identical to the version submitted to the HSA).
- Expedited Review: Available for Class 2–4 novel devices approved for at least one year by one of six major reference regulatory agencies (e.g., US FDA, EU Notified Bodies, TGA, Health Canada).
Both pathways offer benefits, including exemption from Specialist Review fees and shorter processing timelines.
👤 License Holder and Foreign Manufacturers
All import licenses must be held by a locally registered, licensed company in Thailand. This entity serves as the official registrant, coordinates with the TFDA, and retains full ownership and control of the license, offering foreign manufacturers flexibility in their local distribution strategy.
Related Articles
Approximately 5 minutes
Thailand IVD Device Registration: Classification, CSDT, and Local Requirements
In Thailand, IVD registration is managed by the Thai FDA (MDCD) under the Medical Device Act B.E. 2562 (2019), following the 4-tier risk classification of the ASEAN MDD (Listing, Notification, License). Class 2-4 devices require submission in the CSDT format, and some high-risk IVDs need local performance testing.
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.