Regulatory Support for
Medical Devices in Thailand
Thailand stands as a leading hub for medical device commerce in Southeast Asia. At RABT Global, we specialize in regulatory compliance and market entry strategies, providing comprehensive support throughout the medical device approval process in Thailand.
📋 Key Regulatory Highlights
Updated by Ordinance B.E. 2562 (2019)
Quality System Compliance Requirement
TFDA e-Submission System — Since March 16, 2022
Thai or English — Thai Required for Home-Use Devices
Thai FDA — Structured Regulatory Framework
Governed by the Thai Food and Drug Administration (TFDA) under the Ministry of Public Health, Thailand has established a structured and evolving regulatory framework for medical devices.
✅ Class II
✅ Class III
✅ Class IV
⚠️ Key Requirement: International manufacturers seeking to introduce medical devices into the Thai market must work with a registered Local Authorized Representative (LAR) in Thailand to complete regulatory filings and registrations.
Updated Medical Device Classification (Post-2021)
Under the updated regulations aligned with the ASEAN Medical Device Directive (AMDD), the Thai FDA has moved to a risk-based classification model.
Grouping Options: Devices can be organized by Single, Family, System, Set, or IVD categories based on intended use and product name uniformity.
RABT Global’s End-to-End Medical Device Services
We assist you throughout the product lifecycle — from classification and submission preparation through post-market surveillance and license renewal.
Risk-Based Device Classification and Grouping
Determine the correct device class (I–IV) under the TFDA’s risk-based model and organize devices by Single, Family, System, Set, or IVD categories based on intended use.
Class I – IV
Submission Preparation (CSDT and Non-CSDT)
Full preparation of CSDT and Non-CSDT dossiers aligned with TFDA requirements, submitted electronically via the TFDA e-submission system launched on March 16, 2022.
e-Submission
Licensing and Notification Support
End-to-end support for device licensing and notification filings with the Medical Device Control Division (MDCD), ensuring 5-year licenses are obtained efficiently.
5-Year License
Local Representation in Thailand
RABT Global acts as your in-country Local Authorized Representative (LAR) to ensure smooth registration, protect proprietary information, and simplify distributor management.
LAR Services
Labeling, Translation, and Packaging Compliance
Ensure labeling complies with Section 44 of the Medical Device Act, including Thai language requirements for home-use devices and all applicable packaging regulations.
Section 44 Compliance
Import Authorization and Distributor Coordination
Support for import authorization filings and coordination with local distributors to ensure compliant product entry and distribution across the Thai market.
Import Authorization
Change Notification Management
Management of all post-approval change notifications to the TFDA, ensuring any modifications to device design, labeling, or manufacturing are properly filed and approved.
Post-Approval Changes
License Renewal and Holder Transfer
Timely management of 5-year license renewals including Partial Renewal II — requiring full CSDT — and license holder transfers submitted via the TFDA e-submission system.
Renewal & Transfer
Post-Market Surveillance & Incident Reporting
Ongoing post-market surveillance and incident reporting support to maintain regulatory compliance and fulfil all TFDA obligations throughout the device lifecycle.
Post-Market
Local Authorized Representation in Thailand
If you’re a foreign manufacturer without a Thai subsidiary, appointing an independent local agent as your Legal Representative is both practical and secure.
Why Appoint a Local Authorized Representative?
Mandatory for foreign manufacturers without a Thai subsidiary
Required for all foreign manufacturers to complete TFDA regulatory filings
Ensures smooth registration with the Medical Device Control Division (MDCD)
Protects proprietary product and technical information
Simplifies local distributor management and coordination
Practical and secure alternative to establishing a Thai subsidiary
Transition Plan for Existing Approvals
Phased renewal process for devices registered under previous regulations
Devices registered under previous regulations must undergo phased renewal
Partial Renewal II: for certificates with longer validity — full CSDT required
Successful Partial Renewal II grants a new 5-year license
All updates must be submitted via the TFDA’s e-submission system
Revised e-submission guidelines launched on March 16, 2022
Partner with RABT Global for Seamless Thai Market Entry
Our regulatory experts ensure a fast, reliable, and compliant registration process tailored to your business needs — whether you’re entering the Thai market for the first time or navigating regulatory changes.
Risk-Based Device Classification and Grouping
Expert classification under the TFDA’s four-class risk-based model aligned with the ASEAN Medical Device Directive.
Submission Preparation (CSDT and Non-CSDT)
Full dossier preparation and electronic submission management via the TFDA e-submission system.
Licensing and Notification Support
End-to-end licensing and notification support with the Medical Device Control Division (MDCD).
Local Representation in Thailand
RABT Global serves as your registered Local Authorized Representative (LAR) for all TFDA regulatory matters.
Labeling, Translation, and Packaging Compliance
Labeling compliance under Section 44 of the Act including Thai language requirements for home-use devices.
Import Authorization and Distributor Coordination
Import authorization filings and local distributor coordination for compliant product entry into Thailand.
Change Notification Management
Post-approval change notification management to keep device registrations current with TFDA requirements.
License Renewal and Holder Transfer
Timely 5-year license renewals and holder transfers submitted via the TFDA e-submission system.
Post-Market Surveillance & Incident Reporting
Ongoing post-market surveillance and TFDA incident reporting to sustain full regulatory compliance.