Thailand stands as a leading hub for medical device commerce in Southeast Asia. Governed by the Thai Food and Drug Administration (TFDA) under the Ministry of Public Health, the country has established a structured and evolving regulatory framework. 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.
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
- Regulatory Authority: Thai Food and Drug Administration (TFDA)
- Regulation: Medical Device Act B.E. 2551 (2008), updated by Ordinance B.E. 2562 (2019)
- Quality System Compliance: ISO 13485:2016
- Review Division: Medical Device Control Division (MDCD)
- Submission Process: Electronic submission (e-submission)
- Approved Languages: Thai or English (Thai required for home-use devices)
- License Duration: Valid for 5 years
- Labeling Compliance: As mandated under Section 44 of the Act
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:
Class | Risk Level |
Class I | Low Risk |
Class II | Low to Moderate Risk |
Class III | Moderate to High Risk |
Class IV | High Risk |
Grouping Options: Devices can be organized by Single, Family, System, Set, or IVD categories based on intended use and product name uniformity.
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. RABT Global acts as your in-country representative to ensure smooth registration, protect proprietary information, and simplify distributor management.
Transition Plan for Existing Approvals
Devices registered under previous regulations must undergo phased renewal:
- Partial Renewal I: For certificates expiring within 1 year of regulation update—simplified documentation, 3-year validity
- Partial Renewal II: For certificates with longer validity—full CSDT required, 5-year license granted
All updates must be submitted via the TFDA’s e-submission system, launched with revised guidelines on March 16, 2022.
RABT Global’s End-to-End Medical Device Services
We assist you throughout the product lifecycle:
- Regulatory Intelligence and Compliance Strategy
- Risk-Based Device Classification and Grouping
- Submission Preparation (CSDT and Non-CSDT)
- Licensing and Notification Support
- Local Representation in Thailand
- Labeling, Translation, and Packaging Compliance
- Import Authorization and Distributor Coordination
- Change Notification Management
- License Renewal and Holder Transfer
- Post-Market Surveillance & Incident Reporting
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, RABT Global is your dedicated partner for success.
Get in touch today to begin your registration process in Thailand.
