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Singapore Medical Device Registration: Navigating the HSA & Health Products Act
This episode provides a detailed overview of Singapore's medical device registration framework. We cover the role of the Health Sciences Authority (HSA), the foundational Health Products Act 2007 and Medical Devices Regulations 2010, the four-tiered risk classification system, and the various registration pathways available to manufacturers based on prior approvals in reference markets. - What is the primary legislation governing medical devices in Singapore? - How does the Health Sciences Authority (HSA) classify medical devices by risk? - What are the different registration pathways…
The skinny
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