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UDI in Thailand

Thai FDA · MDCD · Draft UDI Guidance March 2025 · Class 2–4 devices

Current Status — Draft Guidance​

In March 2025, Thai FDA released draft guidance introducing Unique Device Identifier (UDI) requirements for Class 2, 3, and 4 medical devices. The guidance is subject to finalisation and a two-year transition period applies for devices already compliant with 2020 labelling rules.

Monitor the Thai FDA website (fda.moph.go.th) and MDCD announcements for the finalised UDI notification and mandatory implementation dates.

What Is UDI?​

A Unique Device Identifier (UDI) is a structured, standardised code on the device label that enables identification and traceability of individual devices or device lots through the supply chain and into clinical use.

The UDI consists of two elements:

  • Device Identifier (DI): Identifies the specific version or model — fixed portion of the UDI
  • Production Identifier (PI): Variable portion — may include lot/batch number, manufacturing date, expiry date, serial number

Scope of Thai UDI Requirements​

Per the March 2025 draft guidance:

Device ClassUDI Required
Class 1Not required (Listing pathway)
Class 2Required — per draft guidance
Class 3Required
Class 4Required

IVDs: Confirm with MDCD whether separate IVD UDI requirements apply.

UDI Format and Issuing Agencies​

Thailand is expected to accept UDIs issued by internationally recognised issuing agencies. Accepted agencies include those recognised by IMDRF member countries:

  • GS1 (GTIN-based UDI) — most widely used globally
  • HIBCC (Health Industry Business Communications Council)
  • ICCBBA (International Council for Commonality in Blood Banking Automation) — for blood-related products

Contact MDCD to confirm which issuing agencies are formally accepted in the finalised Thai UDI notification.

UDI on Labels​

Once UDI requirements are in force, device labels must carry the UDI in:

  • Human-readable form (HIBC or plain text)
  • Automatic Identification and Data Capture (AIDC) form — barcode (linear or 2D) or RFID

For implantable devices, the UDI must appear on all levels of packaging (unit, case, pallet) and may be required on the device itself where technically feasible.

Transition Provisions​

A two-year transition period applies for devices compliant with 2020 labelling rules. Practically:

  • Devices placed on the market before the UDI requirement takes effect may use existing labels until the transition period ends
  • New registrations and renewals after the implementation date must carry UDI-compliant labels
  • Plan label updates to align UDI introduction with routine label revision cycles to minimise disruption

UDI and Post-Market Surveillance​

UDI integration with PMS and recall management:

  • Distribution records should reference UDI (lot/batch number, expiry) to enable traceability
  • In recall situations, UDI enables rapid identification of affected units at all supply chain levels
  • Thai FDA may in future require UDI-based database submission — monitor MDCD announcements

Preparing for UDI​

Steps to prepare now:

  1. Obtain a Company Prefix from GS1 Thailand (gs1th.org) or another accepted issuing agency
  2. Assign GTINs to all Class 2–4 device models
  3. Design updated label artwork incorporating the UDI in both human-readable and AIDC format
  4. Update distribution and traceability systems to capture and record UDI data
  5. Review label compliance timelines and plan implementation aligned with the transition period