ASEAN CT Scanner Market Deep Dive: A Pure Global Guide to Navigating Regulatory Hurdles in Singapore, Thailand, and Indonesia

In this episode of ASEAN MedTech Insights, we delve into the rapidly expanding market for Computed Tomography (CT) scanners in Southeast Asia. We explore the vast differences between mature markets like Singapore, which demand high-tech, AI-integrated systems, and high-growth emerging markets like Indonesia and Vietnam, where the focus is on accessibility and volume. This episode unpacks the complex and fragmented regulatory environment that often surprises global manufacturers. We share a detailed case study of a European company whose market entry into Thailand and Indonesia was delayed by 18 months due to unexpected hurdles with documentation, translation, and local representation requirements, ultimately costing them significant market share. What you'll learn in this episode: - Why is a "one-size-fits-all" approach to the ASEAN market destined to fail for CT scanner manufacturers? - How do the priorities for CT technology differ between Singapore's HSA and Indonesia's Ministry of Health? - What are the most common regulatory documentation mistakes that lead to costly delays in Thailand? - Can a CE mark actually create a false sense of security for companies entering Vietnam or Malaysia? - How does the classification of device software vary across different ASEAN countries? - What is the critical role of a local, in-country representative for post-market surveillance? - Why is building a modular technical dossier a key strategy for multi-country registration? 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. If you're facing the challenges discussed today, contact us at [email protected] or visit https://pureglobal.com/ to learn how we can accelerate your path to market.

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