Following suit with the EU’s implementation of the Unique Device Identification (UDI) system for medical devices, HSA becomes the first Southeast Asian regulatory agency to introduce this system for the country’s medical devices. Thus, they have released guidance concerning such. They intend to help stakeholders in the clarification on the regulatory requirements and detailed steps for the implementation of UDI and submission of information to the SMDR and Class A medical device database. This is a supplemental guideline to other guidance documents that were published beforehand. This includes, but is not limited to, GN – 15, GN – 21, and GN – 23.

UDI System

Singapore will adopt the UDI for the tracking and identification of medical devices. This has a huge impact throughout the supply chain and healthcare system. In order to alleviate the potential problems, a harmonized system will be established to improve the traceability of medical devices that was impacted by recalls, failures, or serious adverse events.

The UDI system is being adopted as it is internationally recognized and is aligned with the harmonized principles published by the International Medical Device Regulators Forum (IMDRF). Implementation of such will lead to:

  • - More efficiency of device traceability, especially during field safety corrective actions (FSCA)
  • - Identification of devices through distribution and use
  • - Timely identification of devices in adverse events
  • - Reduction of medical errors
  • - Longitudinal capture of data in devices

The UDI system comprises of:

  • - Development of UDIs based on globally harmonized standards.
  • - Encoding of UDIs on human-readable interpretation (HRI) and Automated Identification for Data Capture (AIDC).
  • - Submission of other details by the registrants, local manufacturers, and importers such as UDI Databases (UDID). For Class B, C, and D devices, the SMDR will be this and Class A MD database.

UDI Format

The format for the UDI shall be composed of two parts: the UDI Device Identifier (UDI – DI), and UDI Production Identifier (UDI – PI).

  • - UDI – DI: This is a unique alphanumeric code to a specific model of the medical device. This is mandatory and a fixed portion of the UDI and is used as an “access key” to the information stored in the UDID.
  • - UDI – PI: An alphanumeric code that includes the serial number, lot/batch number, software version, and manufacturing and/or expiration date.
  • - Data Delimiters: Included in the HRI and AIDC formats to allow for legible interpretation of the coded information.

The whole UDI format must be presented in the following technology forms: human-readable interpretation (HRI) and Automated Identification for Data Capture (AIDC). Examples of AIDC technologies are linear bar codes, two – dimensional bar codes, QR Codes, and RFID. When an AIDC is scanned using the appropriate reader, it captures the data automatically and is encoded into an electronic patient record or other computer systems. On the other hand, the HRI is a legible interpretation of the data that are encoded in the UDI carrier.

Labeling Requirements for UDI

This is an additional requirement on device labels and is not meant to replace any current marking or labeling requirements as indicated in GN – 23. The following are the labeling requirements for UDI in Singapore:

  • - The UDI must be in HRI and AIDC formats.
  • - The UDI must be placed in the next higher packaging level if space constraints are encountered. Priority will be given to AIDC over HRI if necessary. However, in some setups, HRI is more favored.
  • - The UDI must be encoded for devices required for registration via the Special Access Route (SAR). For devices from the USA or EU markets, the UDI can be used for Singapore.
  • - The UDI is not required for devices that are intended for export only from Singapore and are strictly not for supply locally.
  • - The UDI – PI are not required for devices that are exclusively for retail Point of Sales (POS) directly to consumers.

Data Elements of UDIDs

The data elements of UDIDs differ between the SMDR and Class A databases:

  • - Manual Input via Medical Device Information Communication System (MEDICS) eService Form – this is unique to the SMDR. This includes information about the Issuing Agency, Sterile Medical Device, Description of the Sterilization Method, Device containing Latex, Device Containing DEHP, and Device with Measuring Function.
  • - Excel Upload File – this is common to both SMDR and Class A databases. This includes information about the DM DI Number (if different from UDI – DI), Clinical Size, and SAMD Version. For information unique to Class A databases, this includes UDI – DI, DM DI Number, and Issuing Agency.

Process of Implementing UDI

Manufacturers and product owners are responsible for encoding UDI in HRI and AIDC formats on their products. For devices that are marketed in the USA and EU, the UDI can also be used in Singapore and their information can be submitted as is to the SMDR and Class A databases. For devices not marketed in the USA and EU, UDI implementation is required by choosing an issuing agency designated by HSA, implementation of UDI – DI triggers, and direct marking on the medical devices.

Issuing Agency (IA) are organizations assigned by the Authority for the issuance of UDI for regulatory purposes. Examples of internationally – recognized IAs include GS1, Health Industry Business Communications Council (HIBCC), and the International Council for Commonality in Blood Banking Automation (ICCBA). IAs must be present in Singapore, issues UDIs that conform to international standards with adequate identification of UDIs, make certain that UDIs are available to all users, and ensures that UDI information will be available to the HSA.

UDI – DI triggers allow the tracking of changes made to the DI of a medical device. Tracking of the changes can be monitored by including the following data elements:

  • - Brand name
  • - Device version or model
  • - Clinical size
  • - Labeling as single-use
  • - Sterile packaging
  • - Need for sterilization before use
  • - Quantity of devices provided in a package
  • - Critical warnings or contraindications
  • - New packaging configurations

If a significant change is detected in the medical device, a Change Notification may be required.

Direct marking is the placement of the UDI on the device itself for the purposes of UDI requirements. Several methods are used for such requirements, including intrusive (e.g., dot pin, etching, direct laser, etc.) and non – intrusive methods (e.g., cast/forge/mould, laser bonding, stencil, permanent adhesive label, etc.). The manufacturer is responsible for the legibility of the UDI regardless of the method of placement. They also must ensure that the UDI will not interfere with the safety and performance of the device.

Submission of UDI Data Elements

Data elements for UDI implementation must be submitted to MEDICS, which has been updated to allow the uploading of UDI information. For medical devices that are already registered, the updated MEDICS also allows the submission of UDI – DI and IA information.

How to Submit UDI Information

UDI information can be updated via the new e-service for registered devices. However, only the UDI – DI, Direct Mark – Device Identifier Number (DM – DI), and IA can be updated using this service.

  • 1. Select and add the device listing, DE### (up to 30 device listings per submission).
  • 2. Select “Update UDI info”.
  • 3. A list of current devices under the chosen listing will be shown. Download the Excel file of the list and open it.
  • 4. There will be a column for entering UDI – DI and DM – DI. Fill in the required data. For multiple data, use comma (,) for separation.
  • 5. Save and upload the updated file.
  • 6. Upon successful upload, view and verify the UDI information if successfully updated.
  • 7. Update the IA by checking the box and clicking “Update Form”.
  • 8. It will redirect to the original page and will show “Y” for listings with updated UDI information.
  • 9. Click “Confirm” to complete the submission. A prompt will be shown indicating the Declaration. Clicking “OK” on the prompt means that the declaration is acknowledged.
  • 10. Select “Submit”. If successful, a job reference number will be automatically generated.
    11. The UDI – DI and DM – DI will be updated on the SMDR.

UDI information can also be updated via Change Notification. Unlike the one depicted above; this allows all elements to be updated. This includes the IA, UDI – DI, DM – DI, Sterile medical device and its description, device containing latex and DEHP, a device with measuring function, and Clinical Size. However, the steps to be outlined are only applicable if there are no other changes that require submission as per GN – 21 and for the sole purpose only of updating the UDI.

  • 1. Select Other Changes – Applicable only upon receipt of email from HSA, authorizing submission under this category à Other Notification Changes (Verified by HSA prior to submission).
  • 2. Select and add the device listing, DE###.
  • 3. Click Add/Edit info under Device Infor.
  • 4. Update each radio button and text field accordingly and click “Update Form”.
  • 5. Click Add/Edit info under Model Info(s).
  • 6. Download the Excel file of the list and open it. There will be a column for entering UDI – DI and DM – DI. Fill in the required data.
  • 7. Save and upload the updated file. Click “Update Form”.
  • 8. Upload the Signed Copy of the Declaration on Company Letterhead under Dossier & Supporting Document(s), HSA Email section to confirm that the submission is only for the sole purpose of addition of UDI information.
  • 9. Upon successful upload, click on “Update Form”.
  • 10. Submit the Change Notification application. Refer to GN – 21 for the applicable fees.
  • For submission of UDI information for Class A devices (voluntary basis), the previously submitted Excel file must be downloaded. The UDI – DI, DM – DI, and IA information must be filled in the file, saved, and re-uploaded to update the UDI information.

For submission of UDI information during product registration, the List of Configurations (LoC) is updated to include the new data fields related to UDI same as stated in the Change Notification route. For submission of UDI information for devices required for SAR, the GN – 26, GN – 27, and GN – 29 must be followed. The SAR Device List has been updated to include the IA, UDI – DI, and DM – DI fields.

Rules for Specific Device Types

For non – in vitro diagnostic (IVD) kits, the HRI and AIDC are placed on the outside of the packaging. The devices inside the kit should have UDI carriers on themselves. However, single–use/disposable devices that are part of the kit and are not supplied separately, do not require UDI carrier. For IVD kits, the same rule applies, except that components such as reagents that are not intended for individual use, do not require UDI carrier.

For standalone software/software as a medical device (SaMD), the UDI must contain both DI and PI. Assignment should be on the system level. The software version number can be displayed in the PI.

UDI Implementation Timeline

All Class B, C, and D, as well as in vitro diagnostic (IVD) medical devices are required to implement UDI prior to their marketing in Singapore while Class A devices are required to be listed in their database. To allow for stakeholders to comply with such requirements, the implementation shall be done in phases:

  • 1. Phase 1 – All coronary stents, orthopedic joint replacement implants, and intraocular lens – on or before November 1, 2022.
  • 2. Phase 2 – All Class D general MDs and IVDs – on or before November 1, 2024.
  • 3. Phase 3 – All Class C general MDs and IVDs – on or before November 1, 2026.
  • UDI implementation for Class A devices may be done on a voluntary basis. UDIs are not required for devices that will be used for clinical research, investigative testing, clinical trial, or custom–made devices. An exhaustion period of 6 months will be given to importers to deplete their supply of devices.
    Phase 4 – All Class B general MDs and IVDs – on or before November 1, 2028.

UDI implementation for Class A devices may be done on a voluntary basis. UDIs are not required for devices that will be used for clinical research, investigative testing, clinical trial, or custom–made devices. An exhaustion period of 6 months will be given to importers to deplete their supply of devices.




Guidance on Medical Device Unique Device Identification (UDI) System (currently the link is not working on the website, and QT will update it here when it is back to working)