Singapore HSA adopts Unique Device Identifier system

The Health Sciences Authority (HSA) Singapore has adopted the Medical Device UDI system. This came into effect on 27 August 2021 with the issuing of new UDI Submission Guidelines. The purpose of this system is to improve registered medical devices’ traceability by:

• Enabling timely identification of devices affected by recalls, failures, serious adverse events, Field Safety Corrective Actions
• Supporting medical devices’ identification through distribution records
• Reducing medical errors
• Facilitating data capture of medical devices.

The scope of the UDI system will impact:

• Higher risk class medical devices of Class B, C and D to be registered and supply in Singapore
• Medical devices authorised for supply via Special Access Route (SAR).

In line with the internationally harmonised principles by the International Medical Device Regulators Forum (IMDRF), the UDI system will comprise of:

• the development of Unique Device Identifiers (UDIs) based on globally harmonised standards.
• the placement of UDIs in Human Readable Interpretation (HRI) and Automated Identification for Data Capture (AIDC) formats on all levels of device package labels or in some cases directly marked on the devices.

Additional labelling requirement:

Please note that this inclusion of UDI on medical device package labels is an additional labelling requirement to be fulfilled by product owners and manufacturers. Please refer to GN-23 R1.1 Guidance on Labelling for Medical Devices (published March 2020) on current marking and labelling controls. Where there are space constraints on the labels, the UDI label may be placed on the next higher packaging level and AIDC is the preferred format.

For devices marketed in the EU or USA, UDIs applied on the medical device labels for EU or USA markets will be accepted as is, for an identical labelled use in Singapore.

 For devices not marketed in the EU or USA, product owners are to refer to the issuing agency designated by HSA Singapore i.e., GS1 for implementing UDI on their devices.

Other requirements

 In conjunction with the UDI System, manufacturers must submit data elements mandated by the Health Sciences Authority to the Singapore Medical Device Register (SMDR). In particular, UDI-Device Identifier (UDI-DI) information of registered models will be reflected publicly on SMDR.

The requisite data elements include UDI-DI, Device Mark-Device Identifier (DM-DI), issuing agency, sterility & sterilisation method, presence/absence of latex, DEHP (di(2-ethylhexyl) phthalate) and whether the device has measuring function.

Implications for manufacturers and distributors:

Change notifications

Medical devices undergo changes as part of their product life cycle, if they are considered significant changes such as brand name, device version or model, packaging configuration listed in GN-21-R4.8 Guidance on Change Notification for Registered MD (published 22 March 2021), this may warrant a new UDI-DI identification. This must be submitted as a change notification application.

Non-IVD kits

If the kit or procedure pack is supplied as a single unit, it can be identified with one UDI label. However, if contents within the kit are medical devices in their own right, they are required to have their own UDI label.

IVD kits

Where contents within the kit are medical devices, they are required to have their own UDI label. IVD components such as reagents which are not intended for individual use do not require their own UDI label.

Standalone Software/Software as a medical device (SaMD)

UDI should include both

• UDI-DI: assigned at system level and presented on readily accessible screen
• UDI-Production Identifier (UDI-PI): represented by software version number.

Implementation Timeline

For more information

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