Labeling & UDI
49 articles
MedDeviceRepair: Keeping Loaner Exchanges Traceable When Serial Numbers Change
A three-asset chain-of-custody crosswalk for medical device loaner exchanges: preserve serial traceability across removal, placement, and return without slot-level record overwrites.
HSA GN-21 R7 Change Notification: 6Aii/6Aiii Approval, Two-CN Cap, & August Clock
Singapore HSA GN-21 Revision 7 change notification guide: when 6Aii/6Aiii SMDR updates require approval, the two-active-CN cap, and the 1 August 2026 clock.
Malaysia MDA Automated Re-Registration: MeDC@St 2.0+, July 2026 Switch & CN Trap
Operational guide to Malaysia MDA's Automated Re-Registration Route in MeDC@St 2.0+: six eligibility gates, CN-first sequencing, QMS whitelist, fees, and TAT.
India G.S.R. 743(E): Outsourced Sterilization Labels, 14 Feb 2027 Clock & Ninth Schedule
Guide to CDSCO G.S.R. 743(E) Medical Devices Second Amendment Rules 2026: Rule 44(p) label prefixes, 14 Feb 2027 clock, Ninth Schedule fees, and loan licences.
ISO 20417:2026 Guide: FDA Rec# 5-149, July 1 2029 DoC Window & ISO 15223-1
Operational guide to ISO 20417:2026: FDA Rec# 5-149 complete recognition, the July 1 2029 DoC transition window, ISO 15223-1, 21 CFR 801, and EU MDR GSPR 23.
MDCG 2026-5 UDI Assignment: Manufacturer vs Distributor Decision Tree
MDCG 2026-5 UDI assignment guide: 3-path decision tree for private-label distributor brands, MDR Article 16, Basic UDI-DI rules, and EUDAMED registration.
NSAI NB 0050 Medical Devices Divestment 2026: Stay vs Transfer Playbook
Playbook for NSAI NB 0050 clients on the 2026 divestment: confirmed facts, stay-vs-transfer tree, MDR Article 58, IVDR Article 53, MDSAP.
Pure Global AI: A Practical Workflow Guide for Medical Device Regulatory Teams
A vendor-neutral guide to Pure Global AI's regulatory databases, device and predicate agents, and evidence-first workpapers for risk, eSTAR, CAPA, QMSR, labeling, and post-market review.
FDA Electronic Product Radiation Control (EPRC) for Medical Devices (21 CFR 1000-1050)
Guide to FDA Electronic Product Radiation Control (EPRC) under 21 CFR 1000-1050: 1002.1 matrix, Laser Notice 50/56, Form 2877, and Section 539 civil penalties.
FDA MRI Safety Labeling and GUDID Status: Data Analysis of 5.15M Device Records
Data analysis of 5.15 million FDA GUDID records evaluating MRI safety status distribution, ASTM F2503 labeling rules, implantable device coverage gaps, and 2023 guidance compliance.
EU MDR Article 22: Systems and Procedure Packs — Producer Obligations Guide
Complete guide to EU MDR Article 22 system and procedure pack producer obligations, the no-additional-CE-mark rule, Article 22(4) triggers, UDI, and the FDA convenience-kit comparison.
MDCG 2021-5 Rev.1 EU REP Symbol Transition Guide
A regulatory guide to the MDCG 2021-5 Rev.1 EU REP symbol transition, mapping OJEU decisions, Swiss and UK representative rules, and QMS timelines.
Swissdamed Registry Analysis: 4,554 Swiss Actors and 60,611 Device Registrations
A data-driven analysis of Swissmedic's swissdamed database. We break down actor types, risk classes, legislations, and leading CH-REPs.
Medical Device Accessibility: ADA, Section 508, and EU Accessibility Act Guide
ADA Title II/III, Section 508, WCAG 2.1 AA, and the EU Accessibility Act applied to medical devices, SaMD, patient apps, and infusion-pump screens — what it means for device design.
UDI & Labeling Compared: FDA 801/830, EU MDR, Mexico NOM-137 & China
Legal-text comparison of medical device UDI and labeling: FDA 21 CFR Parts 801 & 830, EU MDR Article 27/Annex VI, Mexico NOM-137-SSA1-2025, and China Order 6/2014 — carriers, databases, and language.
510(k)-Exempt in 2026: How to Check the QMSR, Registration, and UDI Duties You Owe
A 510(k) exemption removes one filing, not your compliance program. How to confirm exempt status and the QMSR, registration, and UDI duties that survive.
GUDID Data-Quality Checklist: What Distributors Should Verify Before a Contract
A portfolio GUDID data-quality checklist for distributors — check labeler completeness, missing descriptions, and identifier integrity per contract.
How to Verify a Medical Device UDI: A GUDID Lookup Workflow for Hospital Purchasing
How to look up and verify a medical device's UDI in FDA AccessGUDID before purchasing, what the DI fields mean, and the data-quality gaps that break a lookup.
EUDAMED After Go-Live: What the First Weeks Reveal and What to Do Next
Post-May 28 EUDAMED compliance reality check: common registration errors, data consistency traps, legacy device triage, NB certificate bottlenecks, and a six-month action plan.
Dermal Fillers vs Cosmetics vs Medicines: Hong Kong Borderline Classification After GN-00
How Hong Kong classifies injectable dermal fillers at the borderline between medical devices, cosmetics, and medicines — and why the May 2026 GN-00 update matters for your product.