Singapore HSA Fees: A Cost Breakdown for Class B, C, & D Medical Device Registration

This episode provides a detailed breakdown of the medical device registration fees charged by Singapore's Health Sciences Authority (HSA). We cover the standard application fee and the specific evaluation costs for Class B, Class C, and Class D devices. The host explains how different evaluation routes—such as Full, Abridged, Expedited, and Immediate—impact the final cost and how leveraging prior approvals from reference agencies can lead to significant savings. - What are the latest HSA registration fees for medical devices in Singapore as of August 2024? - How do evaluation costs differ between Class B, Class C, and Class D devices? - What is the difference in cost between a Full, Abridged, and Expedited evaluation route? - Can prior approval from the US FDA or a European Notified Body reduce my Singapore registration fees? - What is the standard application fee for all device classes? - How can a strategic approach to registration save thousands of dollars per application? - What costs are not included in the official HSA fees? Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies looking to enter markets like Singapore. Our team of local experts, combined with advanced AI and data tools, can help you develop the most efficient regulatory strategy, prepare your technical dossier, and act as your local representative. We streamline the global market access process, helping you navigate complex fee structures and regulatory requirements to get your product to market faster. For more information, visit us at https://pureglobal.com, contact [email protected], or explore our FREE AI tools and database at https://pureglobal.ai.