Labeling & UDI
50 articles
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.
Hong Kong MDACS GN-00 Update: Why Injectable Dermal Fillers Are Now Medical Devices
On 13 May 2026, Hong Kong MDD updated GN-00 to classify injectable dermal fillers as medical devices under MDACS. What changed, why it matters, and what manufacturers must do.
EUDAMED Mandatory Registration: May 28, 2026 Deadlines and UDI Steps
Guide to mandatory EUDAMED registration from May 28, 2026, including actor registration, UDI/device data, certificate linkage, legacy device deadlines, and action steps.
EUDAMED Bulk Upload Validation Error Playbook: Fix XML Rejections
Playbook for diagnosing EUDAMED bulk upload validation errors, including XSD failures, UDI mismatches, EMDN issues, certificate links, DTX codes, and pre-upload checks.
Home-Use IVD Invalid Result Workflow for Consumer Diagnostics
Design and monitor invalid-result workflows for home-use IVDs, including invalid rates, lay-user errors, repeat testing, IFU comprehension, support scripts, and postmarket trending.
RUO-to-IVD Conversion Firewall: Convert Research-Use Assays Without Evidence Risk
Operational guide to converting RUO assays into regulated IVDs, covering claims cleanup, distributor controls, data triage, validation bridging, training, and evidence firewalls.
Global UDI Compliance Deadlines 2026 by Country
Track 2026 UDI compliance deadlines across the EU, Switzerland, Australia, China, Brazil, Singapore, and the US, with class rules and data requirements.
Swissdamed Mandatory July 2026: Swiss Device Registration and UDI Guide
Guide to Switzerland swissdamed mandatory registration from July 1, 2026, covering UDI uploads, Product Module, CH REP duties, M2M, grace periods, and triggers.
Direct-to-Consumer Genetic Tests: FDA, FTC, Privacy, Clinical Validity, and Claims Control
Guide to regulatory, privacy, and commercial risks for DTC genetic tests, including FDA oversight, FTC claim substantiation, clinical validity, GINA, state privacy laws, and risk-report claims.
EUDAMED Registration Mistakes: 10 Errors to Fix Before May 28, 2026
Learn the 10 most common EUDAMED registration mistakes before the May 28, 2026 mandate, including data, UDI, actor, certificate, and workflow errors, plus fixes.
Home-Use and Self-Test IVDs: Pathways, Human Factors, and Labeling
Regulatory guide for home-use and self-test IVDs, covering FDA OTC and CLIA pathways, EU IVDR self-testing, human factors, labeling, specimen errors, and PMS.
ISO 17664 Reprocessing Validation for Reusable Medical Devices
Guide to ISO 17664 reprocessing validation for reusable devices, covering cleaning, disinfection, sterilization, worst-case families, IFU content, FDA expectations, and submission evidence.
Medical Device IFU Reprocessing Instructions: Validated, Audit-Ready Guide
Step-by-step guide to writing validated reprocessing instructions for reusable device IFUs, covering cleaning, sterilization, usability, warnings, and audits.
RUO vs IUO vs IVD Labeling: Research, Investigational, and Diagnostic Boundaries
Practical guide to RUO, IUO, and IVD labeling boundaries, covering intended use, FDA guidance, diagnostic-use triggers, marketing risk, and classification decisions.
Colombia Medical Device Registration Cost 2026: INVIMA Rep Pricing Guide
Buyer-side guide to Colombia Representative pricing models, comparing hourly, annual, and flat-fee registration costs with 3-year cash flow examples.
eIFU for Medical Devices: EU MDR, FDA Rules, QR Codes, and Paper IFUs
Guide to electronic IFU rules for medical devices, covering EU Regulation 2025/1234, FDA 21 CFR Part 801, website access, QR codes, paper fallback, IVDR, SaMD, and validation.
Mexico Medical Device Registration Cost: MRH Pricing Guide (2026)
Compare Mexico MRH pricing models for medical device registration, including flat fees, hourly billing, three-year cash flow scenarios, switching steps, RFP points, and COFEPRIS pathways.
Switzerland Swissmedic Medical Device Registration Guide (2026)
How to register medical devices in Switzerland under Swissmedic: CH-REP duties, MedDO/IvDO rules, swissdamed deadlines, CE reliance, fees, and PMS obligations.
Batch Records for Medical Devices: BMR, EBR, DHR, and FDA QMSR
Guide to batch manufacturing records, electronic batch records, and DHRs for medical devices, covering 21 CFR 210/211, FDA QMSR, ISO 13485, review workflows, deviations, and inspection readiness.
FDA Emergency Use Authorization for Medical Devices: Regulatory Pathway
FDA EUA guide for medical devices covering Section 564 authority, CBRN emergency triggers, submission criteria, EUA vs 510(k)/PMA, termination, and active EUAs.