IVD & Diagnostics
56 articles
VetMedGuide: Building a Useful Veterinary Device Field-Feedback Form
A manufacturer intake worksheet for veterinary analyzer complaints: separate instrument observation, species and matrix, clinic QC evidence, and unsupported causality.
MDCG 2026-4: Who Uploads SSCP and SSP to EUDAMED, the Handover, and 2027 Clocks
MDCG 2026-4 EUDAMED SSCP and SSP upload guide: NB interim duties, manufacturer handover in October 2026, Article 32 vs 29(4), and the 27 February 2027 clock.
CDSCO Medical Device Software Guidance 2026: MDSW Classes, Portals & Change Protocols
Navigate India's CDSCO MDSW guidance: SaMD qualification, Class A–D risk matrix, NSWS vs cdscomdonline portals, Algorithm Change Protocols, and MDR-2017 rules.
CMS CY 2027 OPPS: Software as a Medical Service (SaMS) & Status Indicator O1
CMS-1850-P proposed SaMS policy: status indicator O1, Table 61 vs Table 62, CLFS-to-APC rate mismatch, and the August 31, 2026 comment deadline.
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.
IVDR Performance Study Requirements: Application vs Notification, Timelines, and Reporting
Comprehensive guide to IVDR Chapter VI performance studies: Article 58 application triggers, Article 70 PMPF notifications, Article 66 timelines, leftover samples, and safety reporting.
Medicare CLFS Under PAMA: What IVD & Diagnostic Developers Must Know in 2026
Comprehensive 2026 guide to Medicare CLFS lab payment under PAMA: applicable lab rules, 3-year CDLT cycle, ADLT status, gapfilling, and CAA 2026 Section 6226 updates.
Mongolia Diagnostic & IVD Device Register Teardown: 2024 LMMD Reset
A data-driven teardown of Mongolia's diagnostic and IVD register. Analyze the risk-class split, country-of-origin mix, top manufacturers, and 2024 LMMD regulatory reset.
Bangladesh DGDA Registered Medical Devices Teardown: Chinese IVDs & Class C Majority
A data-driven teardown of Bangladesh's Directorate General of Drug Administration (DGDA) registered medical device list, analyzing risk classes, manufacturers, and importers.
Why One FDA/CE Clearance Opens Far Fewer CGM Markets: The Global Class-Divergence Map
A comprehensive cross-market analysis of continuous glucose monitor (CGM) classification, clinical trial requirements, and reimbursement gates across the US, EU, China, Japan, and Canada.
Zambia ZAMRA Medical Device Registry Teardown: Manufacturers & LTRs
A data-driven teardown of Zambia's ZAMRA medical device and IVD registry. Explore risk-class splits, country of origin trends, and LRP channel concentration.
Ecuador ARCSA Medical Device Register Analysis: 326,334 Records
A data-driven teardown of Ecuador's ARCSA medical device registro sanitario: 326,334 listed records, 22,056 registrations, risk classes I-IV, device types, and titular concentration.
El Salvador DNM Medical Device Registry: 21,607 Approvals & Importer Dynamics
An in-depth analysis of El Salvador's medical device registry (DNM/SRS). Understand active vs. cancelled ratios, risk classes, and top local importers.
Ethiopia Medical Device Registry: 5,915 Approvals & Local Dynamics
A comprehensive teardown of the Ethiopian Food and Drug Authority (EFDA) eRIS database. Review manufacturer origins, top local importers, and regulatory steps.
Uzbekistan Medical Device Registry: 6,572 Approvals & Entry Trends
A data-driven analysis of Uzbekistan's Uzpharm State Register. Discover registration volumes, product categories, and leading foreign suppliers.
China NMPA Device Registration: 14,187 Approvals, Import Mix, and Foreign Wins
A data-driven analysis of China's NMPA medical device registry database. Discover approval volumes, import vs. domestic splits, and strategic pathways for foreign device makers.
WHO Medical Device and IVD Prequalification: The Complete Regulatory Guide
A comprehensive guide to the World Health Organization (WHO) prequalification process for medical devices and IVDs, detailing eligibility, step-by-step pathways, and key 2026 procedural updates.
IVD Registration Compared: FDA 809, EU IVDR, China, Brazil & India
Side-by-side legal-text comparison of IVD registration: FDA 21 CFR Part 809, EU IVDR 2017/746, China SAMR Decree 48, Brazil RDC 830/2023, India MDR 2017 — classes, pathways, who reviews.
IVD Calibrator Traceability: ISO 17511, EU IVDR, and JCTLM Guide
Metrological traceability for IVD calibrators and control materials under ISO 17511:2020 and EU IVDR Annex I Section 9.3, covering calibration hierarchies, JCTLM resources, and common pitfalls.
Abbott Libre Duo CE Mark: Dual Glucose-Ketone CGM Strategy (2026)
Abbott Libre Duo CE mark analysis covering the first continuous glucose-ketone sensor, dual-analyte regulatory strategy, CGM competition, FDA pathway, and wearable convergence.