Navigating Thailand's New AMDD Regulations: Why Pure Global's On-the-Ground Experts in Bangkok Are Essential for Your MedTech Success

Thailand is a top-tier MedTech market in ASEAN, but its regulatory landscape is shifting. With new rules aligned with the ASEAN Medical Device Directive (AMDD), foreign manufacturers face a critical hurdle: the mandatory appointment of a Local Authorized Representative (LAR). This isn't just a name on a form; it's a legal and strategic necessity. This episode of ASEAN MedTech Insights dives deep into the challenges and solutions for entering the Thai market. We explore why using a distributor as your LAR can be a costly mistake, how on-the-ground expertise in Bangkok is non-negotiable for smooth dealings with the Thai FDA, and how to maintain full control over your business assets while ensuring compliance. Imagine launching your innovative device in Thailand, only to find your market access held hostage by a distributor who owns your product license. Switching partners becomes a nightmare, costing you months of sales and thousands in re-registration fees because they control your legal gateway to the market. This episode explains how to avoid this exact scenario. Key Takeaways: * What are the specific legal risks of appointing your distributor as your Local Authorized Representative in Thailand? * How does Thailand's alignment with the AMDD practically change your technical dossier submission? * Why is having a physical presence in Bangkok more critical than ever for dealing with the Thai FDA? * What legal liabilities does your LAR hold, and how does that directly impact your business? * How can you regain control of your product registration if it's already held by a sales partner? * What are the three most common pitfalls foreign MedTech companies face when entering the Thai market? * Why is separating your regulatory and commercial strategies essential for long-term growth in ASEAN? Pure Global offers end-to-end regulatory consulting solutions, acting as your independent Local Authorized Representative in Thailand and over 30 other markets. We combine on-the-ground local expertise with advanced AI tools to streamline your global market access. Don't let regulatory hurdles block your expansion. Contact us at [email protected] or visit https://pureglobal.com to secure your market presence.

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