Singapore HSA COVID-19 IVD Reclassification: Class C Requirements from 2026

Singapore's Health Sciences Authority (HSA) is reclassifying all COVID-19 in-vitro diagnostic (IVD) tests from the highest-risk Class D to Class C, effective June 2, 2026. This episode details the reasons for this regulatory shift as COVID-19 becomes endemic, explains the differences between Class C and Class D requirements, and outlines the practical impact on technical documentation, quality management systems, and post-market surveillance for IVD manufacturers marketing products in Singapore. Key Questions: - What is the new risk classification for COVID-19 IVD tests in Singapore? - Why did Singapore's Health Sciences Authority (HSA) make this change? - When does this new classification officially take effect? - How does the Class C regulatory pathway differ from the Class D pathway for IVDs? - What are the specific changes to technical documentation and submission requirements? - Will existing COVID-19 IVDs need to be re-registered under the new class? - How does this reclassification impact post-market surveillance obligations? - What immediate actions should regulatory teams take to prepare for this transition? Sources: - https://www.morulaa.com/singapore-hsa-announces-regulatory-updates-for-medical-devices-ivds/ - https://www.hsa.gov.sg/medical-devices/guidance-documents How Pure Global can help: Navigating regulatory changes like Singapore's IVD reclassification requires local expertise and a clear strategy. Pure Global provides comprehensive support for MedTech and IVD companies, acting as your local Singapore Registrant and managing the entire registration process. Our team of experts and advanced AI tools can help you efficiently update your technical dossiers, adapt your quality management system, and ensure a seamless transition to the new Class C requirements. To learn how we can accelerate your market access in over 30 countries, visit us at https://pureglobal.com, contact us at [email protected], or explore our free regulatory AI tools and device database at https://pureglobal.ai.