Introduction
Thailand’s medtech sector is fast emerging as a hub for innovation and regional market access. With the country aligning its medical device regulatory system to the ASEAN Medical Device Directive (AMDD), manufacturers targeting Thailand must now adhere to stricter, harmonized requirements, starting with accurate device classification.
However, classification is not merely an administrative checkbox. It’s the foundation of your regulatory strategy for Thailand. An incorrect classification can lead to serious consequences, from registration delays and increased costs to outright regulatory rejection.
For companies looking to succeed in Thailand, understanding how the Thai FDA classifies medical devices under AMDD is crucial, and more nuanced than it may initially seem.
1. AMDD & Risk-Based Classification: A Quick Overview
The ASEAN Medical Device Directive (AMDD) aims to create a unified framework for regulating medical devices across ASEAN member states, including Thailand. Under this framework, devices are classified based on risk to the patient and user, taking into account factors such as duration of use, invasiveness, and whether the device is active or passive.
The Thai FDA has adopted AMDD classification principles, grouping devices into Class 1 (low risk) to Class 4 (very high risk).
Sounds simple? In theory, yes. But in practice, classification depends on a mix of intended use, technology, and local regulatory interpretation — and that’s where many manufacturers misstep.
2. The 4 Classes: What You Should Know
Here’s a simplified breakdown of the four classes under Thailand’s AMDD-aligned framework:
Class 1 – Low Risk
These devices typically include items like surgical gloves, basic thermometers, or non-invasive dressings. Though documentation requirements are lighter, compliance must still be demonstrated, especially with post-market responsibilities.
Class 2 – Low-Moderate Risk
Examples may include infusion pumps or diagnostic reagents. Classification often hinges on how the product is used, and seemingly minor variations in intended use can shift a product from Class 2 to Class 3.
Class 3 – Moderate-High Risk
Think of implantable orthopedic devices or anesthesia machines. These require significantly more technical documentation, including risk management reports and clinical data, which must meet Thai FDA expectations.
Class 4 – Very High Risk
This includes life-supporting or life-sustaining devices, such as implantable defibrillators. Expect rigorous scrutiny, lengthy evaluations, and detailed justifications across all technical files.
Note: Classification determines your entire submission scope from cost and timelines to the level of scrutiny your application will face. One incorrect assumption at this stage can cascade into months of back-and-forth with regulators.
3. Common Mistakes by Manufacturers
We’ve observed several recurring pitfalls that can derail even the most promising market entries:
- Assuming the device class based on its classification in another country (like the US or EU).
- Using outdated or unofficial sources found online without verifying against the Thai FDA’s actual regulatory notices.
- Underestimating the importance of classification in pre-submission planning.
- Lack of internal alignment between product management and regulatory teams.
- More often than not, the Thai FDA will challenge the proposed classification, especially if the justification is vague or copied from another market.
4. Why Expert Support Matters
Correct classification is the first strategic decision you’ll make in your Thai FDA journey. It’s not just about checking a box — it’s about making sure your documentation, costs, and timelines are aligned with reality.
At Titans Medical Consulting, we’ve helped manufacturers avoid:
- Costly classification errors
- Redundant testing or documentation
- Prolonged delays due to rejected submissions
- We work closely with your internal teams to craft a tailored classification strategy that anticipates scrutiny and minimizes surprises, right from the start.
Conclusion
Thailand’s classification process under AMDD may look straightforward on paper, but it requires in-depth regulatory insight and local experience to navigate confidently.
Whether you’re bringing a Class 1 diagnostic kit or a Class 4 implantable system to market, you don’t have to figure it all out alone.
Titans Medical Consulting helps medical device manufacturers navigate classification, documentation, and end-to-end registration with the Thai FDA, ensuring compliance, clarity, and confidence in your market entry.
Sources
- Thai FDA – Medical Device Control Division: https://www.fda.moph.go.th/sites/Medical/
- ASEAN Medical Device Directive (AMDD): https://asean.org/book/asean-medical-device-directive-amdd/
- Ministry of Public Health, Thailand: https://www.moph.go.th/
- WHO – ASEAN Regulatory Harmonization: https://iris.who.int/handle/10665/255530