Labeling & UDI
27 articles
Arabic Labeling, UDI & Halal Certification for Medical Devices in MENA (2026)
Country-by-country labeling requirements for medical devices across MENA — Saudi Arabia (Arabic+English mandatory), UAE (Arabic with equal prominence), Egypt (Arabic or English), Israel (Hebrew+Arabic+English for consumer), Turkey (Turkish for consumer). Halal certification frameworks (GSO 2055-1:2015, SFDA-approved logos, UAE MOIAT, Qatar MOPH). UDI requirements across Saudi Arabia, UAE, Egypt, and Turkey.
Is It a Medical Device? Borderline Product Classification for Hand Sanitizer, Mouthwash, Personal Lubricants & Data Recorders Across FDA, EU MDR, Brazil ANVISA and Mexico COFEPRIS
How to classify four common borderline products — hand sanitizer, mouthwash, personal lubricants, and data recorders — across FDA, EU MDR, Brazil ANVISA, and Mexico COFEPRIS. Includes decision trees, regulation citations, and jurisdiction-by-jurisdiction comparison tables.
EUDAMED Day Zero: The Role-Specific Action Playbook for Manufacturers, Authorized Representatives, Importers, and Distributors (Final 50 Days Before May 28, 2026)
Role-by-role action playbook for the May 28, 2026 EUDAMED mandatory deadline — covering actor registration, UDI/device registration, certificate uploads, and market surveillance obligations with a countdown checklist and member-state penalty matrix.
QMSR Gap Analysis for ISO 13485:2016 Certified Companies: The 50+ Item Checklist for FDA's New Quality System Rule
Clause-by-clause gap analysis checklist mapping ISO 13485:2016 to FDA's QMSR — covering terminology changes, complaint handling, labeling controls, UDI integration, record retention, and 50+ specific action items your QMS documents still need.
Colombia INVIMA Medical Device Registration: Complete Guide for Foreign Manufacturers (2026)
Everything you need to know about INVIMA medical device registration in Colombia — covering classification (Classes I–III), uncontrolled vs controlled pathways, Decree 4725 requirements, UDI-DI compliance, fees, timelines, legal representation, and post-market surveillance obligations for 2026.
EUDAMED Registration: Complete Guide for Medical Device & IVD Manufacturers (2026 Deadlines)
Step-by-step guide to EUDAMED registration — Actor Module (SRN), UDI/Device Module, Notified Bodies & Certificates, and Market Surveillance. Covers mandatory deadlines from May 2026, legacy device requirements, and compliance strategies.
Medical Device Labeling & UDI System: The Complete Regulatory Guide
Master FDA and EU MDR medical device labeling requirements, UDI system implementation, GUDID database submissions, and global UDI harmonization — practical guide with compliance checklists and common pitfalls.