LabelNex · Compliance

Regulatory compliance is not a feature. It is the foundation.

Every label carries regulatory weight. GHS for chemicals. GS1 for supply chain. UDI for medical devices. FDA 21 CFR for food and pharma. EU MDR for European medical devices. We make compliance audit-ready.

Regulatory Frameworks

Compliance expertise across global regulations.

GHS / CLP

Globally Harmonized System and EU Classification, Labeling and Packaging. Signal words, pictograms, H/P phrases, SDS-to-label alignment. Multi-market and multi-language variant management.

UN GHS Rev.10 · EU CLP · REACHGHS details →

GS1 Standards

GTIN, SSCC, GLN, GS1-128, GS1 DataMatrix, GS1 Digital Link. Barcode verification and print quality standards for global supply chain compliance.

GTIN · SSCC-18 · GS1-128 · Digital LinkGS1 details →

UDI / EU MDR

Unique Device Identification for FDA and EU Medical Device Regulation. UDI-DI, UDI-PI, direct marking, and GUDID/EUDAMED database submission.

FDA UDI · EU MDR · GUDID · EUDAMEDUDI details →

FDA 21 CFR

Food labeling (Part 101), pharma labeling (Part 201), electronic records (Part 11), and medical device labeling (Part 801).

21 CFR 101 · 201 · 11 · 801FDA details →

Digital Product Passport

EU DPP readiness. EPCIS events, product identity data, and supply chain traceability for regulated and export-heavy manufacturers.

EU DPP · EPCIS · GS1 Digital Link

Country-Specific

India BIS, China GB standards, Brazil ANVISA, Japan PMDA, Korea MFDS. Multi-jurisdiction label compliance for global manufacturers.

BIS · GB · ANVISA · PMDA · MFDS