/ Regulatory Standards

One identifier, six regulatory regimes.

Whether you’re shipping medical devices into the EU, generics into the GCC, or supplements into the United States, UCC Global identifiers are formatted, registered, and resolvable in line with the local authority.

/ FDA · United States

21 CFR · DSCSA · UDI

Drug Supply Chain Security Act-aligned serialization and aggregation. Unique Device Identification (UDI) submissions for the GUDID database with FDA-format Application Identifiers.

/ SFDA · Saudi Arabia

RSD Track-and-Trace

Saudi FDA Drug Track-and-Trace (RSD) ready. Reporting events for commissioning, aggregation, shipping, and decommissioning streamed to the central authority.

/ JFDA · Jordan

Bilingual Track-and-Trace

Jordan FDA serialization mandate coverage with Arabic / English bilingual labelling support and tamper-evidence metadata for cross-border consignments.

/ EU · European Union

FMD & MDR UDI

Falsified Medicines Directive (FMD) compliance with NMVS gateway connectivity, plus Medical Device Regulation (MDR) UDI submission for EUDAMED.

/ NMPA · China

Export Coding

National Medical Products Administration export-coding alignment for medicines, devices, and cosmetics shipped from Chinese manufacturing hubs.

/ CDSCO · India

PIB Tracking

Central Drugs Standard Control Organisation Product Identification Barcoding (PIB) tracking for exported pharmaceutical formulations.

/ Manufacturing Hubs

From the floor in Shenzhen to the shelf in Stuttgart.

We’ve optimized our standards for the world’s highest-volume production corridors. Plant-level operators get pre-validated label templates; head office gets a single source of truth for every code in circulation.

  • China — Shenzhen, Suzhou, and Guangzhou export packing
  • India — Hyderabad, Mumbai, and Ahmedabad formulation lines
  • European Union — Ireland, Germany, and Poland packaging hubs
  • GCC region — Saudi Arabia and UAE distribution centres
  • North Africa — Egypt and Morocco regional manufacturing
Asia-Pacific
China · India
High-volume export
Europe
EU FMD Zone
NMVS connectivity
Middle East
GCC · Levant
SFDA · JFDA
North America
US · Canada
DSCSA · UDI · HC
Africa
N. Africa
Regional export
LATAM
Brazil · Mexico
ANVISA · COFEPRIS
06.
Health Authorities
60+
Export Markets
04.
Aggregation Layers
ISO.
Aligned Standards

Map your compliance footprint with us.

Tell us your target export markets — we’ll return a compliance gap analysis and a coding plan that clears every gate.