『ASEAN MedTech Insights by Pure Global: A Deep Dive into Singapore's HSA Class C Device Registration - Common Pitfalls and Expedited Pathways』のカバーアート

ASEAN MedTech Insights by Pure Global: A Deep Dive into Singapore's HSA Class C Device Registration - Common Pitfalls and Expedited Pathways

ASEAN MedTech Insights by Pure Global: A Deep Dive into Singapore's HSA Class C Device Registration - Common Pitfalls and Expedited Pathways

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 This episode of ASEAN MedTech Insights provides a detailed guide on registering a Class C medical device with Singapore's Health Sciences Authority (HSA). We explore the critical role of reference agency approvals from bodies like the US FDA and EU Notified Bodies, and how they can unlock expedited pathways, significantly reducing your time to market. We break down the specific requirements for the fastest route, the Expedited Class C Registration (ECR-1), and highlight the common, costly mistakes that can derail your submission. This is a must-listen for any MedTech company looking to successfully launch a moderate-to-high-risk device in the strategic Singaporean market. Imagine your innovative Class C device, already successful in Europe, facing unexpected nine-month delays in Singapore. The problem? A tiny discrepancy in the 'intended use' statement between your submissions, caused by a minor software update. This single oversight, a common pitfall we discuss, can cost you months of lost revenue and thousands in additional fees, pushing your entire ASEAN launch schedule off-track. Key Takeaways from this Episode: 1. What are the different evaluation routes for Class C devices in Singapore, and which one is the fastest? 2. How can prior approval from a reference agency cut your HSA review time by more than half? 3. What are the three specific criteria your device must meet to qualify for the Expedited Class C Registration (ECR-1) route? 4. Why is having an identical "intended use" statement the most critical part of your application? 5. What is the Common Submission Dossier Template (CSDT), and which documents are most frequently missed by applicants? 6. Why can't a foreign manufacturer directly register their device in Singapore? 7. What is the role of a Singapore Registrant, and how does this appointment impact your market access? 8. What are the most common reasons for HSA to reject an expedited registration application? Pure Global offers end-to-end regulatory consulting solutions for Medical Technology (MedTech) and In-Vitro Diagnostic (IVD) companies, combining local expertise with advanced AI and data tools to streamline global market access. Let us help you navigate the complexities of the ASEAN market. Contact Pure Global at info@pureglobal.com or visit us at https://pureglobal.com/.
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