With a population exceeding 70 million, Thailand has emerged as a dynamic medical hub. The country's medical device sector is poised for growth, fueled by investment incentives and medical tourism.
The introduction of new medical device regulations by Thailand’s Food and Drug Administration (Thai FDA) in 2021 aligns with the ASEAN Medical Device Directive (AMDD), promising a more structured and transparent Thailand medical device registration process.
Thailand’s medical devices market will reach $2.29B by 2025 (6.22% CAGR), and the IVD market$1.63B by 2030 (6.3% CAGR). Growth is driven by rising healthcare spending (3.7% of GDP), an aging population (13.7% 65+ in 2021), and high medical device imports ($2.1B in 2023).
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Determine whether the product qualifies as a medical device under Thai FDA regulations. Identify the appropriate device class based on risk and intended use and conformity assessment route: Listing (Class 1), Notification (Class 2 and 3), or Licensing (Class 4).
Foreign manufacturers must appoint a Local Authorized Representative (LAR) to act as the License Holder and serve as the main liaison with the Thai FDA. The LAR must be based in Thailand and obtain an Establishment License.
Compile a comprehensive registration dossier in Thai or English. Device Listing for Class 1 devices requires minimal documentation; Classes 2–4 devices must submit a complete technical dossier in the CSDT format and an acceptable GMP certificate. Thai FDA may allow abridged or reliance pathways with streamlined documentation for devices with prior authorizations from the US FDA, EU Notified Bodies, TGA, Japan MHLW, Health Canada, Singapore, or WHO. The LAR submits the application electronically to the Thai FDA.
The Thai FDA conducts a detailed review of the submitted application. Upon successful evaluation and compliance with regulatory standards, the Thai FDA issues a license authorizing the product for market entry. Licenses are valid for five (5) years.
Maintain compliance with timely renewals and post-market obligations, including maintaining device records and annual reporting, vigilance reports for adverse events in and outside Thailand, labeling compliance, and advertising approvals in accordance with Thai FDA requirements. Begin the renewal process at least 9-12 months before the license expires.
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.
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.
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.
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.
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.
When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
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