Singapore UDI Update: Mandatory Requirements for Class C Medical Devices Take Effect in November 2026

The Singapore Health Sciences Authority (HSA) has established requirements for the implementation of the Unique Device Identification (UDI) system for medical devices under GN-36: Guidance on Medical Device Unique Device Identification (UDI) System, Revision 2, published in July 2022.

As Singapore continues to roll out its UDI framework in phases, medical device companies need to prepare for new requirements covering product labeling, UDI assignment, and submission of UDI data to the relevant database.

⏰ A new phase of Singapore’s UDI implementation is approaching. Following the mandatory implementation for all Class D medical devices and certain other device categories, all Class C medical devices will be subject to mandatory UDI requirements from November 1, 2026. Companies should therefore begin their compliance preparations now.

1. Key Features of Singapore’s UDI Framework

1. Adoption of an internationally harmonized UDI system

Singapore’s UDI framework is based on internationally recognized UDI principles and is aligned with the principles established by the International Medical Device Regulators Forum (IMDRF).

The UDI system generally requires companies to:

• Assign a globally standardized Unique Device Identifier (UDI) to medical devices;
• Place the UDI on medical device labels, packaging levels, or, where required, directly mark the device itself; and
• Submit the required data elements to the relevant UDI database.

2. UDI consists of UDI-DI and UDI-PI

Singapore’s UDI system consists of two main components:

(1) UDI-DI — Device Identifier

The UDI-DI is the fixed portion of the UDI used to identify a specific medical device model or version. It is primarily used to link the device to the corresponding product information in the UDI database.

(2) UDI-PI — Production Identifier

The UDI-PI identifies production-related information associated with the device, such as:

• Serial number;
• Lot or batch number;
• Software version;
• Manufacturing date; and
• Expiration date.

3. Existing EU and U.S. UDI information can be accepted

For medical devices that have already been labeled in accordance with U.S. or EU UDI requirements, existing UDI information may be used to meet Singapore’s UDI requirements.

HSA specifically provides for the use of UDI information already appearing on labels for the EU or U.S. markets.

💡 What this means for manufacturers

For companies targeting both the European and U.S. markets as well as Singapore, this can reduce the need for duplicate UDI assignment and unnecessary label changes.

2. Phased Implementation Timeline

According to the HSA guidance, Singapore’s UDI implementation is being introduced in phases based on the risk classification of medical devices.

Key takeaway:
With November 1, 2026 approaching, manufacturers of Class C medical devices and IVDs should review their UDI readiness and complete the necessary preparations in advance.

3. Key UDI Compliance Requirements

1. Medical devices must be assigned a UDI

Medical devices within the applicable scope must have a compliant UDI assigned in accordance with Singapore’s requirements.

2. Labels must include UDI in both AIDC and HRI formats

UDI labeling must generally include both:

• AIDC (Automatic Identification and Data Capture); and
• HRI (Human Readable Interpretation).

AIDC technologies may include:

• Barcodes;
• QR codes;
• RFID; and
• Other applicable automatic identification technologies.

Depending on the device and packaging configuration, the UDI should be provided on:

• The lowest level of packaging intended for sale;
• Higher levels of packaging, where applicable; and
• The device itself through direct marking, where required.

3. UDI data must be submitted to the HSA database

Manufacturers or other responsible parties must submit the required UDI data elements to the relevant HSA database.

Depending on the applicable device, such information may include:

• UDI-DI;
• Issuing Agency;
• DM-DI, where applicable; and
• Relevant product information.

4. Requirements for issuing agencies

HSA recognizes internationally established UDI issuing agencies, including GS1, HIBCC, and ICCBBA.

At present, the issuing agencies designated for use in Singapore include GS1 and HIBCC.

5. Changes to a device may trigger a new UDI-DI

Certain changes to a medical device may require the manufacturer to assess whether a new UDI-DI must be assigned.

Examples include changes to:

• Brand name;
• Product model or version;
• Product dimensions;
• Single-use status;
• Sterilization status;
• Number of units in a package;
• Critical warnings or other safety information; and
• New packaging configurations.

⚠️ Important reminder

If a change to the UDI-DI is associated with a significant change to an already registered medical device, the manufacturer may also need to submit a change notification or a new pre-market submission, depending on the nature of the change and applicable HSA requirements.

4. Practical UDI Compliance Recommendations for Manufacturers

1. Prioritize products already marketed in the U.S. or EU

For products that are already marketed in the United States or European Union and have UDI labeling in place in accordance with local requirements, manufacturers should first assess whether the existing UDI can be used for Singapore.

In many cases, there may be no need to establish an entirely separate UDI system for Singapore.

Manufacturers should therefore first verify:

• Whether a UDI has already been assigned under FDA requirements;
• Whether an EU UDI strategy has been established or is under development; and
• Whether the current product label already includes the required UDI information.

2. Plan UDI assignment and label updates in advance

For products that have not yet implemented UDI, manufacturers should:

• Select an appropriate UDI issuing agency;
• Assign the UDI-DI;
• Determine the applicable UDI requirements for different packaging levels; and
• Update product labeling accordingly.

📌 Responsible party

The manufacturer or product owner is responsible for correctly assigning the UDI and ensuring that the UDI is appropriately placed on the label, packaging, or device itself in accordance with the requirements of the selected issuing agency.

3. Prepare UDI database information in advance

Manufacturers should prepare the relevant information required for UDI database submission, including:

• Product model information;
• UDI-DI;
• Packaging configuration;
• Sterility information;
• Software version information, where applicable; and
• Product dimensions, where applicable.

Companies should also ensure that the information submitted to the UDI database is consistent with the product’s existing registration and regulatory documentation.

5. Conclusion

Singapore is continuing to implement its UDI framework progressively according to medical device risk classification. The overarching goal is to improve traceability throughout the medical device lifecycle and enhance patient safety.

For medical device companies entering or operating in the Singapore market, UDI compliance involves far more than simply adding a code to the product label. It also requires companies to establish an appropriate UDI assignment strategy, maintain database information, manage packaging configurations, and assess UDI implications when products change.

With mandatory UDI requirements for Class C medical devices and IVDs scheduled to take effect on November 1, 2026, companies should begin their compliance planning as early as possible to ensure that their products can continue to be supplied to the Singapore market in accordance with HSA requirements.