This episode of MedTech Global Insights delves into the strategic importance and regulatory complexities of the Singaporean medical device market. We explore the Health Sciences Authority (HSA) framework, from device classification and the Common Submission Dossier Template (CSDT) to the critical role of a local Singapore Registrant. Discover how to navigate these challenges effectively. We share a detailed case study of a European IVD manufacturer that struggled with delays and submission errors when trying to enter the Singapore market alone. Learn how they overcame these hurdles with a strategic partner, leveraging existing approvals and advanced AI tools to expedite their registration, saving crucial time and resources. What You'll Learn: - Why is Singapore a critical entry point for the broader ASEAN MedTech market? - What are the most common and costly mistakes to avoid when preparing your CSDT submission for the HSA? - How can you strategically use your existing FDA or CE mark approvals to accelerate your Singapore registration? - What legal responsibilities does a Singapore Registrant hold, and how do you select the right partner? - How can modern AI and data tools slash the time and costs associated with compiling technical files? - What are the key differences in registration pathways for Class B, C, and D devices? - What post-market surveillance obligations must you meet after your device is approved in Singapore? Contact us at [email protected] or visit https://pureglobal.com/