Medical Device Classification
in Thailand
Thailand regulates medical devices under a risk-based classification system aligned with the ASEAN Medical Device Directive (AMDD).
Medical devices are classified according to their intended use and level of patient risk.
Risk Classification
Medical devices are generally classified into four classes:
Class 1– Low Risk
Examples include:
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Surgical instruments
-
Examination gloves
-
Wheelchairs
These products typically have simpler regulatory requirements.
Class 2– Low to Moderate Risk
Examples include:
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Infusion pumps
-
Hypodermic needles
-
Suction equipment
Additional technical documentation is usually required.
Class 3– Moderate to High Risk
Examples include:
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Orthopedic implants
-
Diagnostic imaging equipment
-
Hemodialysis equipment
These devices undergo more comprehensive technical review.
Class 4 – High Risk
Examples include:
-
Heart valves
-
Implantable pacemakers
-
Coronary stents
These products require the highest level of regulatory scrutiny.
Medical Device
Registration Requirements
Depending on device classification, the registration package may include:
Risk analysis
Device description
Software validation (if applicable)
Clinical evaluation report
Administrative documents
Manufacturer information
Performance testing
Essential Principles checklist
Intended use
Labeling
Sterilization validation
ISO 13485 certification
Instructions for Use (IFU)
Biocompatibility data
Most Class 2–4 devices require a Common Submission Dossier Template (CSDT) in accordance with ASEAN requirements.