『Pure Global's ASEAN MedTech Insights: Leveraging Your CE Mark or FDA Approval for Expedited Medical Device Registration in Thailand』のカバーアート

Pure Global's ASEAN MedTech Insights: Leveraging Your CE Mark or FDA Approval for Expedited Medical Device Registration in Thailand

Pure Global's ASEAN MedTech Insights: Leveraging Your CE Mark or FDA Approval for Expedited Medical Device Registration in Thailand

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 In this episode of ASEAN MedTech Insights, we tackle a crucial question for global MedTech manufacturers: Can your existing CE mark or FDA approval fast-track your medical device registration in Thailand? We dive into the specifics of the Thai FDA's expedited pathways, explaining how you can leverage your prior approvals to gain a competitive edge in one of Southeast Asia's most dynamic markets. We explore the "Concise Evaluation Route," detailing which device classes are eligible and what the process actually entails. This is not a simple green light; it's a streamlined review that still demands meticulous preparation. A U.S. diagnostics company learned this the hard way. They assumed their FDA approval was a golden ticket into Thailand, only to face significant delays due to misunderstandings about local license holder requirements and the specific format needed for their technical documentation, costing them an estimated six months in lost revenue and market momentum. Key Takeaways: * What exactly is Thailand's "Concise Evaluation Route" and does my device qualify? * Is my FDA 510(k) or CE mark an automatic passport to the Thai market? * Beyond my approval certificate, what key documents does the Thai FDA still require? * Why is a local Thailand license holder mandatory even with an expedited application? * How can I format my existing technical files to meet the ASEAN CSDT standard? * What are the most common mistakes that lead to delays, even on an expedited pathway? * Are there language requirements for labeling and instructions that I need to know? * How does the expedited process in Thailand compare to other ASEAN countries like Malaysia or Vietnam? Struggling to turn your global approvals into rapid ASEAN market access? Pure Global offers end-to-end regulatory consulting, combining local expertise with advanced AI to streamline your entry into over 30 global markets. We act as your local representative and ensure your submission is right the first time. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn more.
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