Thailand Medical Device Classification: Risk Categories and Thai FDA Verification

Thailand Medical Device Classification System

Medical device classification in Thailand is administered by the Thai Food and Drug Administration (TFDA) and follows a risk-based approach closely aligned with the ASEAN Medical Device Directive (AMDD). Classification determines the regulatory route required for market authorization: Listing, Notification, or License.

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⚙️ Risk Categories (Class 1-4)

Devices are classified into four categories, ranging from the lowest risk (Class 1) to the highest risk (Class 4). The primary factors considered for classification include:

• Intended Use: The purpose and indications of the device.
• Risk Level: The potential harm posed to the patient and user.
• Delivery Method: How the device is introduced (e.g., non-invasive, surgically invasive).
• Invasiveness: The degree of penetration into the human body.

Risk Class	Risk Level	Required Approval Route
Class 1	Lowest Risk	Listing Approval
Class 2	Low to Moderate Risk	Notification Approval
Class 3	Moderate to High Risk	Notification Approval
Class 4	Highest Risk	License Approval

🔬 IVD Classification Rules

In-Vitro Diagnostic (IVD) devices are also classified into the same four categories (1 through 4), with specific rules guided by the AMDD. Factors unique to IVD classification include:

• Expertise of the User: Whether the device is for self-testing or professional use.
• Public Health Impact: The consequence of an incorrect result on the individual and public health.
• Examples of High-Risk IVDs (Class 4 License): Tests for transmissible agents like HIV, HCV, and HBV.

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🌐 Official Classification Verification

To avoid misclassification, manufacturers can formally query the Thai FDA to confirm their product's classification and grouping:

1. Online Submission: The applicant submits a classification request via the electronic system (e-submission portal).
2. Review Process: The TFDA officer reviews the submitted intended use, materials, and risk profile based on the classification rules.
3. Certification: Upon approval, the applicant receives an official document certifying the medical device's risk classification and grouping. This process requires paying both a submission fee (1,000 THB) and an approval fee (500 THB).