Summary
Singapore's Health Sciences Authority (HSA) has published its Guidance on the Medical Device Unique Device Identification (UDI) System, adding yet another regional UDI database to the global compliance map. The system is built on internationally harmonized IMDRF principles, so a UDI that meets U.S. or EU requirements generally suffices, but the device-specific rules in Section 4 align with the EU, not the U.S., for convenience kits and software. The heaviest lift for most companies is submitting UDI data to the existing Singapore Medical Device Register (SMDR) for Class B, C, and D devices and to the Class A medical device database, with up to 10 additional data attributes per device.
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In May 2021, the Singapore Health Sciences Authority (HSA) published draft guidance for their proposed Unique Device Identification (UDI) system.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.
A New SaMD Definition
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 harmonized 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.
Watch the divergence: “Aligned to IMDRF” does not mean identical to the U.S. FDA UDI Rule. The device-specific rules in Section 4 follow the EU UDI requirements, so a program built solely around U.S. assumptions can produce noncompliant submissions in Singapore. Map each market's rules to your device types before you build a single submission file.
Where Singapore Aligns With the EU, Not the U.S.
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 Real Work: Submitting UDI Data to the SMDR
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
Because these attributes feed a regulated registry, the accuracy and traceability of every field matter. Strong data integrity practices keep these device records consistent across the U.S., EU, and Singapore so a single source of truth drives every regional submission rather than a patchwork of one-off spreadsheets.
Two Ways to Submit the Data
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.
A Practical Framework for Multi-Region UDI Compliance
- Build one authoritative device data model. Capture every UDI attribute once, then map it to U.S. FDA, EU MDR, and Singapore HSA rules so you submit consistent data to each registry.
- Flag the divergences early. Note where Singapore follows the EU (convenience kits, software/physical-media UDI parity) versus the U.S., and resolve those rules at the device-type level before generating submissions.
- Validate the systems that hold the data. The applications managing UDI records are GxP-relevant, so apply risk-based Computer Software Assurance (CSA) and document the controls that keep submissions trustworthy.
- Protect the electronic records. Treat UDI submission data and audit trails as records subject to 21 CFR Part 11 expectations for accuracy, attributability, and integrity.
- Keep it compliant over time. Use Cloud Assurance to maintain the validated state as guidance and registries evolve.
How USDM Can Help
Each new regional UDI database adds attributes, deadlines, and rule variations that strain device data, labeling, and the systems that manage them. USDM helps medical device companies turn fragmented UDI requirements into a single, validated, audit-ready process, from data integrity and system validation through ongoing compliance, so every regional submission draws from the same trusted source.
FAQ: Singapore HSA UDI Implementation
Does a U.S. or EU UDI satisfy Singapore's UDI requirements?
The HSA guidance states that Singapore's UDI system is aligned to the internationally harmonized IMDRF principles, and that a UDI meeting U.S. or EU requirements would suffice. However, the device-specific rules in Section 4 align with the EU, not the U.S., so alignment is not automatic for every device type.
Where does Singapore's UDI guidance diverge from U.S. requirements?
Two areas stand out. For convenience (“non-IVD”) kits, all devices in the kit need their own UDI except single-use disposables used solely as part of the kit, whereas in the U.S. no devices in a convenience kit need a UDI. For standalone software and SaMD, the physical media and software UDI must be identical in Singapore, while in the U.S. they can be – and often are – different.
What UDI data must be submitted to the Singapore Medical Device Register (SMDR)?
For Class B, C, and D devices, up to 10 additional data attributes are required, including Issuing Agency, sterility and sterilization method, latex and DEHP content, measuring function, UDI-DI, Direct Mark UDI-DI, clinical size, and SaMD version number. For Class A devices, only the Issuing Agency, UDI-DI, and (if used) DM DI are required.
How do companies submit or update UDI data in Singapore?
There are two paths. The “Submission of Update of Unique Device Identifier (UDI)” e-service lets registrants update or add three specific elements (IA, UDI-DI, DM-DI) for already registered devices. For broader changes, the change notification MEDICS e-service allows submission and updating of all UDI data elements.
What does the HRI requirement involve?
The human readable interpretation (HRI) is a legible, plain-text interpretation of the data characters encoded in the UDI carrier, typically presented adjacent to or below the AIDC carrier. Singapore's HRI requirements are more aligned to the U.S. approach and call out data delimiters (e.g., GS1 (01), (11)) that allow legible interpretation of the coded information.
Ready to simplify multi-region UDI compliance? Contact USDM to build a validated, audit-ready UDI data and submission process that scales across the U.S., EU, and Singapore.