TFDA Thailand Medical Device Registration
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.
Complying with Thailand's FDA Regulations
Regulatory Authority
Pure Global can assist with Thailand's medical device registration, ensuring FDA approval to sell in the Thai market.
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.
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.
Let's Talk,
Anywhere You Are.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.