UDI labelling will be introduced in Singapore for medical devices
Singapore’s Health Sciences Authority (HSA) will introduce a Unique Device Identification (UDI) system for medical devices starting from 2022.
Following the US and EU steps, Singapore, among other countries such as Brazil, Saudi Arabia, and China, started implementing a new UDI system. The main reason of this decision is to standardise the labelling of medical devices and in-vitro diagnostic devices.
UDI code from the US and EU will therefore be considered valid by Singapore’s HAS as it is, and does not require further modifications. Its implementation will start in 2022 with high risk implantable devices, and will follow with medium risk devices with other three phases. Low- risk medical devices will not require a UDI code, but they can be applied voluntarily by the manufacturer.
These codes will then be registered in the SMDR (Singapore Medical Device Register).