Following suit with the EU’s implementation of the Unique Device Identification (UDI) system for medical devices, HSA becomes the 1st South East Asian regulatory agency to introduce this system for the country’s medical devices. For now, they have issued a draft guidance document for consultation. 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 that was published beforehand.

UDI System

No system is currently in place for the identification or coding of medical devices in Singapore. This has a huge impact on their tracking and identification 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.

Singapore will adopt the UDI System which is internationally recognized as it 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 will comprise 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).

Labeling Requirements for UDI

The following are the labeling requirements for UDI in Singapore:

  • - The UDI must be in HRI and AIDC format and shall be placed in all packaging, smallest to largest. Some devices may even be required to be encoded with UDI on the device itself.
  • - Devices that followed the Special Access Route (SAR) are still required to be labeled with UDI.
  • - Shipping containers need not implement UDI.
  • - Medical devices that are considered for retail Point of Sale (POS) directly to consumers need not encode UDI – PI in AIDC.

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, issue 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
  • - Labelling 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 UDI on the device itself. Reusable MDs will be useful to have printed UDIs on the devices. However, manufacturers and product owners should be careful in placing UDIs directly as it may impact the safety and performance of the device or the technological feasibility to do such. Evaluation of the direct marking must then be carried out. The direct marking DI must be submitted directly to the SMDR or Class A database.

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.

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. 1. Phase 1 – All coronary stents, orthopedic joint replacement implants, and intraocular lens – on or before November 1, 2022.
  2. 2. Phase 2 – All Class D general MDs and IVDs – on or before November 1, 2024.
  3. 3. Phase 3 – All Class C general MDs and IVDs – on or before November 1, 2026.
  4. 4. 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.

 

 

References:

 Consultation for Guidance on the Medical Device Unique Device Identification (UDI) System

 Guidance on Medical Device Unique Device Identification (UDI) System

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