The Singapore Health Sciences Authority (HSA) published their Guidance on Medical Device Unique Device Identification (UDI) System.
In May 2021, the Singapore Health Sciences Authority (HSA) published draft guidance for their proposed Unique Device Identification (UDI) system. On 27 August 2021, they published their Guidance on Medical Device Unique Device Identification (UDI) System regulatory guidance (the draft and final guidance are very similar), frequently asked questions about the medical device UDI system, and a UDI-DI submission video.
Perhaps adhering to their risk classification guidelines for Software as a Medical Device (SaMD), the final guidance adds a definition of SaMD:
STANDALONE MOBILE APPLICATION (as set out in the Regulations): A software and/or mobile application that is intended to function by itself and are not intended for use to control or affect the operation of other hardware medical devices.
From an implementation standpoint, the guidance states that the “fundamental elements of [the] UDI system in Singapore [are] aligned to the internationally harmonised principles published by the International Medical Device Regulators Forum (IMDRF).” As such, they state that a UDI that meets U.S. or EU UDI requirements would suffice for Singapore.
However, it is important to note that Section 4 of the Guidance on Medical Device Unique Device Identification (UDI) System regulatory guidance, the rules for specific device types is extracted from the IMDRF UDI guidance and aligns with the EU UDI requirements and *NOT* the U.S. requirements. Specifically:
- For convenience (“non-IVD”) kits – all devices within the kit need their own UDI, except SUDs (in the U.S., no devices in the convenience kit need a UDI): “If the contents within the kits are medical devices, they should have a UDI Carrier on their packaging or on the device itself. However, for individual single-use disposable medical devices packaged within a Kit, which are meant for use solely as part of the kit and not used or supplied individually, are not required to have their own UDI Carrier.”
- For Standalone Software and SaMD – the physical media and software UDI must be the same (in the U.S., the UDIs can be – and often are – different): “The UDI assigned to the first packaging of the physical medium and the system level Standalone Software and SaMD should be identical.”
It is not clear how those two ideas will align. Conversely, the human readable interpretation (HRI) format (plain text) requirements are more aligned to the U.S. requirements (and the recent FDA finalized form and content guidance). That is, it specifically calls out the Data Delimiters that allow legible interpretation of the coded information (e.g., GS1 (01), (11)) are required to be part of the HRI.
HRI is a legible interpretation of the data characters encoded in the UDI carrier, typically presented adjacent to or below the AIDC carrier, as shown here.
The biggest issue for most companies, though, is the submission of UDI data to the existing Singapore Medical Device Register (SMDR) for class B, C, and D medical devices, and the Class A medical device database for Class A medical devices. The UDI data required to be submitted is the same as in the regulatory guidance. The 10 (additional) data attributed (for class A devices, only Issuing Agency (IA), UDI-DI, and, if used, DM DI) are:
- IA (i.e., GS1, Health Industry Business Communications Council [HIBCC], or International Council for Commonality in Blood Banking Automation [ICCBBA])
- Sterile – yes/no
- Description of sterile medical device (i.e., the sterilization method(s) to be used – as a text string) – e.g., EO sterilization, Radiation sterilization
- Device containing latex – yes/no
- Device containing DEHP – yes/no
- Device with measuring function – yes/no
- UDI-DI (e.g., Global Trade Item Number [GTIN])
- Direct Mark UDI-DI (DM DI) Number (only if different from UDI-DI)
- Clinical Size – including Volume, Length, Gauge, Diameter (free text string)
- SaMD Version number
There are two ways to enter the data, which are described in both the guidance and the video:
- For already registered devices – the new e-service “Submission of Update of Unique Device Identifier (UDI)” will allow registrants to update or add three specific UDI data elements (IA, UDI-DI, DM-DI) for their registered medical devices, assuming that the other required information is entered and correct.
- For devices needing to modify all or some of the UDI data attributes, the change notification MEDICS e-service allows the submission and updating of all of the UDI data elements.
Compliance dates are listed here: