Last 19 October 2020 the Health Sciences Authority (HSA), Singapore’s Regulatory Authority, announced that it will be introduced a UDI (Unique Device Identification) system to be used for Medical Devices. UDI implementation will take place gradually.
HSA will accept the UDI labels of the EU and U.S.A devices
HSA decided to introduce the UDI system in order to start to comply internationally with the labelling requirements of Medical Devices and IVDs, consistently with other countries such as Europe and the United States, where the implementation of the UDI system is well under way or it is about to be, and with China, Brazil e Saudi Arabia.
In this regard, HSA will consider valid the UDI codes that Manufacturers have applied on the labels of Medical Devices in Europe and in the United States without any need for modification. In addition, the information of these labels together with other information will be collected and published in the Singapore Medical Device Register (SMDR) database.
UDI labels will only be required for medium-high risk Medical Devices, while they will not be necessary for low-risk Medical Devices (Class A).
Implementation of the UDI system will begin in 2022
The first phase of UDI system implementation will begin in 2022 with specific high-risk implantable devices, followed by three successive phases which will take place every two years:
- in 2024 all other Class D Medical Devices;
- in 2026 all Class C Medical Devices;
- in 2028 all Class B Medical Devices.
Manufacturers of devices involved in the first phase will have to send the information to SMDR before the beginning of 2022 and these products will be required to bear UDI labels starting at that time. Once the first stage in completed, HSA will analyse the results to see if changes should be made to the labelling requirements or to the database.
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