Streamlining Your Entry into Thailand's Growing Medical Device Market

With a population exceeding 70 million and a strategic position in the ASEAN region, Thailand has emerged as a dynamic medical hub. The country's medical device sector is poised for growth, fueled by investment incentives and a resurgence in medical tourism. The introduction of new medical device regulations by Thailand’s Food and Drug Administration (FDA) in 2021 aligns with the ASEAN Medical Device Directive (AMDD), promising a more structured and transparent regulatory environment.

Device Classification and Regulatory Pathways

Complying with Thailand's FDA Regulations

Regulatory Authority

Thailand's FDA has adopted regulations that classify medical devices into four categories based on risk, in line with the AMDD. The regulatory process now requires that Class 2-4 medical device applications be submitted using the Common Submission Dossier Template (CSDT). For foreign manufacturers, appointing a local Authorized Representative (AR) is essential for navigating the registration process and ensuring compliance.

Classification

Devices are categorized from Class 1 (low risk) to Class 4 (high risk), with varying levels of documentation and review required. Class 1 devices generally require less documentation, while Classes 2-4 must comply with more stringent submission guidelines.

Key Requirements

To market in Thailand, manufacturers must:

  • Appoint a local Authorized Representative (AR) to interact with the Thai FDA.
  • Register medical devices prior to importation, adhering to the Thai FDA’s classification manual.
  • Understand that registration licenses are valid for five years for Class 1 devices, and four years for Classes 2-4.
How We Can Help

Tailored Support for Market Entry

Our expertise facilitates seamless market access:

  • Assistance with product classification and determination of the regulatory pathway.

  • Compilation of the technical dossier in CSDT format for Thai FDA submission.

  • Acting as your Authorized Representative, handling the registration process with the Thai FDA and managing post-market compliance.

We Provide Access To 28+ Markets Worldwide

Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.

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