This video explains how to register medical devices in Thailand under the Thai FDA’s AMDD-aligned regulations, including risk-based classification, licensing requirements, and the mandatory role of a Local Authorized Representative. Learn how to navigate Thailand’s USD $2.29 billion medtech market efficiently and compliantly. Pure Global’s experts in Bangkok streamline your entry into Thailand and the broader ASEAN region.
This video gives medical device manufacturers a detailed guide to entering Thailand’s rapidly growing medical device market, one of the most dynamic in the ASEAN region. With over 70 million people, a booming medical tourism industry, and strong government investment incentives, Thailand offers a lucrative environment for innovative medtech solutions. By 2025, the market is projected to reach USD $2.29 billion (6.22% CAGR), while the in-vitro diagnostics (IVD) segment is forecast to hit USD $1.63 billion by 2030. Rising healthcare spending, an aging population, and increasing imports—valued at USD $2.1 billion in 2023—are driving demand.
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The Thai Food and Drug Administration (Thai FDA), part of the Ministry of Public Health, regulates the country’s medical device sector. In 2021, Thailand introduced new regulations aligned with the ASEAN Medical Device Directive (AMDD), creating a more structured and transparent registration process. Devices are classified into four risk-based categories: Class 1 (low risk) to Class 4 (high risk). Documentation and review requirements increase with the device class, while Class 1 devices require basic submissions, higher classes demand more extensive evidence and regulatory scrutiny.
Before a product can be marketed or imported, manufacturers must register it in accordance with the Thai FDA’s classification manual. Licenses are valid for five years for Class 1 devices and four years for Classes 2–4. For companies without a legal entity in Thailand, appointing a Local Authorized Representative (AR) is mandatory. The AR manages all interactions with the Thai FDA, prepares and submits the Common Submission Dossier Template (CSDT), and ensures ongoing compliance, including post-market surveillance.
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Pure Global’s Bangkok-based team combines on-the-ground expertise with AI-powered dossier tools to reduce review timelines and eliminate regulatory bottlenecks. From classification strategy and CSDT assembly to license maintenance and ASEAN-wide rollouts, we streamline every step so you can focus on innovation. Learn more about TFDA Thailand Medical Device Registration.
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