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Cracking the Code of Thai FDA Approval: Pure Global's Expert Insights on Complying with Thailand’s Medical Device Act B.E. 2551 for ASEAN MedTech Innovators.
This episode of ASEAN MedTech Insights unpacks the essential steps to comply with Thailand’s Medical Device Act B.E. 2551. We explore the Thai FDA's risk-based classification system, the different registration pathways available to foreign manufacturers, and the critical role of a local authorized representative.
Navigating this landscape is challenging. For example, a company with a successful, FDA-approved device might assume a smooth entry into Thailand, only to face unexpected delays and costs. Their submission gets stuck because their technical file isn't in the required ASEAN CSDT format, and key documents haven't been translated into Thai, highlighting how a lack of local expertise can become a significant barrier to market access.
In this Episode, We Unpack:
1. What are the four risk classes for medical devices in Thailand and how do they determine your registration path?
2. Why is appointing a local authorized representative in Thailand an absolute must for foreign companies?
3. How can your existing approvals from the US, EU, or Canada dramatically speed up your registration process in Thailand?
4. What is the ASEAN CSDT, and why is it the mandatory format for your technical file?
5. What are the specific Thai language labeling requirements that can halt your product launch if overlooked?
6. Which registration pathway—Full, Concise, or Verification—is the right one for your MedTech device?
7. What are the most common documentation mistakes that lead to rejection by the Thai FDA?
8. After your device is approved, what are your ongoing legal responsibilities for post-market surveillance?
Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies, combining local expertise with advanced AI to streamline global market access in Thailand and beyond. To ensure your product navigates the Thai FDA's requirements efficiently, contact us at [email protected] or visit https://pureglobal.com/.
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By Ran ChenThis episode of ASEAN MedTech Insights unpacks the essential steps to comply with Thailand’s Medical Device Act B.E. 2551. We explore the Thai FDA's risk-based classification system, the different registration pathways available to foreign manufacturers, and the critical role of a local authorized representative.
Navigating this landscape is challenging. For example, a company with a successful, FDA-approved device might assume a smooth entry into Thailand, only to face unexpected delays and costs. Their submission gets stuck because their technical file isn't in the required ASEAN CSDT format, and key documents haven't been translated into Thai, highlighting how a lack of local expertise can become a significant barrier to market access.
In this Episode, We Unpack:
1. What are the four risk classes for medical devices in Thailand and how do they determine your registration path?
2. Why is appointing a local authorized representative in Thailand an absolute must for foreign companies?
3. How can your existing approvals from the US, EU, or Canada dramatically speed up your registration process in Thailand?
4. What is the ASEAN CSDT, and why is it the mandatory format for your technical file?
5. What are the specific Thai language labeling requirements that can halt your product launch if overlooked?
6. Which registration pathway—Full, Concise, or Verification—is the right one for your MedTech device?
7. What are the most common documentation mistakes that lead to rejection by the Thai FDA?
8. After your device is approved, what are your ongoing legal responsibilities for post-market surveillance?
Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies, combining local expertise with advanced AI to streamline global market access in Thailand and beyond. To ensure your product navigates the Thai FDA's requirements efficiently, contact us at [email protected] or visit https://pureglobal.com/.