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 Thailand medical device registration process.
Complying with Thailand's FDA Regulations
Regulatory Authority
Medical devices sold in Thailand are regulated by the Thai Food and Drug Administration, a division of the Ministry of Health. Pure Global can assist with Thailand's medical device registration and act as your Authorized Representative, 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.
Frequently
Asked Questions
What is the regulatory authority for medical device registration in Thailand?
Thailand's Food and Drug Administration (FDA) is the regulatory authority responsible for the registration and compliance of medical devices in Thailand. The regulations introduced in 2021 align with the ASEAN Medical Device Directive (AMDD) and are overseen by the TFDA.
How are medical devices classified in Thailand?
Medical devices in Thailand are classified based on risk from Class 1 (low risk) to Class 4 (high risk). The level of documentation and review required increases with the risk class, with Class 1 devices requiring less documentation and Classes 2-4 needing more stringent submission guidelines for Thailand medical device registration.
What are the key requirements for manufacturers to market medical devices in Thailand?
Manufacturers must appoint a local Authorized Representative (AR) to interact with the Thai FDA. They must also register their medical devices prior to importation, following the Thai FDA’s classification manual. According to Thailand medical device registration requirements, registration licenses are valid for five years for Class 1 devices and four years for Classes 2-4.
How long are registration licenses valid for medical devices in Thailand?
Registration licenses in Thailand are valid for five years for Class 1 medical devices and four years for Classes 2-4. Manufacturers must adhere to these timelines to ensure continued compliance and market access under Thai FDA registration requirements.
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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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Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.