Unique Device Identification (UDI)

What is UDI?

Unique Device Identification (UDI) is used to identify medical devices clearly and consistently. GS1 is an issuing agency for UDI, which means GS1 standards can be used to support UDI regulatory requirements.

A UDI usually consists of two parts:

  • UDI-DI: The device identifier, usually your GS1 barcode number.
  • UDI-PI: Production information such as batch number, expiry date, manufacturing date or serial number.

How to Get Started with UDI

For GS1 Malaysia Members

If your company is an active GS1 Malaysia subscriber and already uses GS1 barcode numbers on your products, you may already have the foundation needed for UDI-DI.

What you should do:

  1. Use your GS1 barcode number as the UDI-DI.
  2. Check whether your product also requires UDI-PI.
  3. If UDI-PI is required, include details such as batch number, expiry date, manufacturing date or serial number.
  4. Encode the required information into the correct barcode symbol.
  5. Check with your regulatory or compliance team before finalising your label.

Contact GS1 Malaysia

For Non-GS1 Malaysia Members

If your company is not yet a GS1 Malaysia member, you will need to join GS1 Malaysia first to obtain a GS1 Company Prefix. This allows you to create official GS1 barcode numbers for your medical devices.

What you should do:

  1. Apply for GS1 Malaysia membership.
  2. Obtain your GS1 Company Prefix.
  3. Create GS1 barcode numbers for your medical devices.
  4. Use the barcode number as the UDI-DI.
  5. Seek guidance from GS1 Malaysia if you need support for UDI implementation.

Apply for GS1 Membership

Important Note

UDI requirements may differ by country, product type and regulatory authority. Companies should always confirm the final labelling and submission requirements with their compliance team or relevant regulatory agency.

For products supplied to Europe, there may also be a requirement for Basic UDI-DI, also known as Global Model Number (GMN). Basic UDI-DI is not the same as your GTIN or barcode number and is not printed on the product label.

Need Help with UDI?

GS1 Malaysia can provide guidance or training to help your team understand how to implement UDI using GS1 standards.

Enquire Now