Thailand FDA Regulatory News

Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.

Regulatory Framework

Regulatory Authority: Thai FDA (Food and Drug Administration), under the Ministry of Public Health

Key Legislation:

• Medical Device Act B.E. 2551 (2008)
• Ministerial Regulations on Medical Device Standards
• ASEAN Medical Device Directive (AMDD) signatory

Classification: Risk-based, 4 classes (aligned with ASEAN AMDD):

• Class 1 (low risk) | Class 2 (low-medium risk) | Class 3 (medium-high risk) | Class 4 (high risk)

Registration Pathway:

1. Class 1: Notification (listing)
2. Class 2: Notification with technical documentation
3. Class 3/4: Full registration with Thai FDA review
4. Appoint a local license holder/importer
5. Submit via Thai FDA online system (CSDT format)

Key Requirements:

• Product License or Notification required before marketing
• Local license holder (importer) mandatory for foreign manufacturers
• CSDT documentation format (ASEAN harmonized)
• Thai-language labeling and IFU required
• Manufacturing quality system (ISO 13485)
• Establishment License for manufacturers and importers
• Clinical evidence for Class 3/4 devices

Current Key Guidance:

• Thai FDA Medical Devices (English)
• Thai FDA Medical Device FAQ
• ASEAN AMDD Framework & CSDT Guide
• ASEAN Standards & Conformance (Official)

Latest Updates

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