Thailand Medical Device Regulations

Medical Device Classification in Thailand

Thailand Medical Device Regulations

Thailand’s health authority adopts a risk-based classification approach for medical devices and in vitro diagnostics (IVDs), ensuring a streamlined regulatory process. Devices are categorized into four risk classes:

• Class I: Low-risk, including Animal Medical Devices (requires listing).
• Class II: Low-moderate risk (requires notification).
• Class III: Moderate-high risk (requires notification).
• Class IV: High risk (requires licensing).

To determine the appropriate registration route, manufacturers must classify their devices following the ‘Risk Classification of Non-In Vitro Diagnostic Medical Devices Annexed to the Notification of the Ministry of Public Health Re: Risk Classification of Medical Devices, B.E. 2562 (2019)’. This guideline defines the rules for proper risk classification and compliance with Thailand's Medical Device Regulations.

How Qserve Supports Regulatory Compliance in Thailand
Qserve offers expert guidance to help you classify your devices accurately and follow the correct registration route based on Thailand’s regulations. From classification to submission, our team ensures a smooth market entry process.

Registration routes Thailand

Registration process

Any individual or organization intending to manufacture or import medical devices for sale in Thailand must apply for product registration with the Thai Food and Drug Administration (Thai FDA). The Thai FDA offers three distinct registration pathways:

• Full Evaluation
  The full evaluation pathway follows the standard listing, notification, or licensing process, depending on the device’s risk classification. This pathway ensures compliance with the risk-based classification rules outlined by the Thai FDA.
• Concise Pathway
  The Concise Pathway is an expedited route that recognizes approvals from reference agencies or leverages the World Health Organization (WHO) prequalification. This approach shortens the review time, providing a faster option for market entry when these conditions are met.
• Reliance Program
  The Reliance Program is another fast-track option, relying on Singapore’s Health Science Authority (HSA) approvals. This program significantly accelerates the medical device registration process for devices already approved in Singapore.

These expedited pathways reflect the Thai FDA's commitment to streamlining market access for medical devices while maintaining regulatory compliance.