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e-Labeling

What Is e-Labeling?​

e-Labeling refers to the provision of the Instructions for Use (IFU) in electronic format — typically via a QR code on the device or packaging linking to a web-hosted document — rather than as a printed insert.

Permenkes No. 11 of 2025 formally recognises e-labeling as a valid method for providing instructions for medical devices in Indonesia. This aligns Indonesia with international trends and with similar provisions in the EU (REGULATION (EU) 2021/2226 on electronic IFU) and other markets.

When e-Labeling Is Permitted​

Permenkes 11/2025 permits e-labeling specifically for devices intended for professional use in clinical settings (hospitals, clinics, medical professionals). For such devices:

  • The IFU may be provided electronically via a durable QR code on the device or packaging
  • The linked URL must be maintained for the lifetime of the device on the Indonesian market
  • The electronic IFU must be in Bahasa Indonesia (BI language requirement applies equally to e-labeled IFUs)

When Physical Labels Remain Mandatory​

Physical printed labels in Bahasa Indonesia are still mandatory for:

  • High-risk devices (Class C and D) intended for home use or patient self-administration
  • Consumer/patient-facing devices where immediate access to safety information is essential
  • Emergency situations — all warnings and safety-critical information must be immediately accessible without internet connectivity

The "safety priority" rule: Even where e-labeling is used, any warnings, contraindications, dosing information, or critical safety instructions must be available in a physical format in Bahasa Indonesia. The physical label cannot simply redirect to a QR code for safety-critical content.

Practical e-Labeling Compliance Approach​

For professional-use devices where e-labeling is appropriate:

  1. Place a durable QR code on device/packaging linking to the hosted BI IFU
  2. Include on the physical label: device name, NIE, manufacturer, LAR, lot/expiry, storage, warnings, and the QR code
  3. Ensure the hosted IFU is maintained and accessible throughout the device's Indonesian market life
  4. Include a brief statement directing users to access the full IFU electronically
  5. Submit the e-labeling approach (including the QR code target URL and the physical label design) as part of the Regalkes dossier

Ongoing URL Maintenance​

The electronic IFU URL must remain active for the entire period the device is on the Indonesian market. If the URL changes, a change notification via Regalkes is required. URL expiry or inaccessibility constitutes a labeling non-compliance.