Episode Details

This episode delves into a key regulatory pathway in Singapore for low-risk medical devices. We explore the Health Sciences Authority's (HSA) exemption from product registration for Class A non-sterile devices, a crucial topic clarified by guidance from June 1, 2022. We detail the specific requirements that are waived, as well as the crucial obligations that remain, such as dealer licensing and post-market surveillance. This is essential listening for any MedTech company looking to enter the Singaporean market efficiently with a low-risk product portfolio. - What is Singapore's Class A medical device registration exemption? - Does my low-risk, non-sterile device need to be registered with the HSA? - If product registration is not required, what licenses do I still need? - What are the post-market responsibilities for exempt devices in Singapore? - Who is responsible for correctly classifying a medical device to qualify for the exemption? - How can this pathway accelerate my entry into the Singaporean market? Pure Global streamlines global market access for MedTech and IVD companies. For Singapore, we act as your local representative, manage dealer licensing, and ensure your regulatory strategy leverages pathways like the Class A exemption. Our experts, supported by advanced AI tools, help you compile technical dossiers and manage post-market compliance, ensuring a fast and compliant entry. Access over 30 markets with our end-to-end solutions. Visit us at https://pureglobal.com, contact info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.