Singapore HSA Releases Information on Import and Supply of Unregistered Medical Devices

The Health Sciences Authority (HSA) Singapore has provided some guidance on the import and supply of unregistered medical devices by the request of qualified practitioners in August 2022. 

Approval from HSA is required for doctors or dentists to import these unregistered devices. Some of the acceptable justifications include for compassionate use, to prevent an out-of-stock crisis, and if the device itself is novel or established. 

Additionally, the medical device will also need to comply with other requirements such as the Radiation Protection Act (governed by the National Environment Agency). 

More details can be found in “Import and supply of unregistered medical devices by request of qualified practitioners, August 2022”:  

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