Reimbursement & Market Access
113 articles
Bahrain NHRA: 3 ARs Hold 55% of Devices — Small GCC Market Channel Lock-In
Bahrain NHRA device database analysis: 62 ARs manage 1,491 devices, top 3 hold 55%, all tracked licenses expired, and manufacturer-AR lock-in is high. GCC channel strategy implications.
Canada MDALL Class III/IV Analysis: US Companies Hold 48% of High-Risk Listings
US companies hold 48% of Canada's 57,000 Class III/IV MDALL listings. Median device age is 9.7 years and 49% of devices are over a decade old. Full data analysis.
Korea MFDS: J&J, Medtronic, Stryker Dominate High-Risk Device Imports
Korea MFDS data shows 13,117 licence holders manage 273,672 registrations. Top 20 holders control 14.4%. US firms dominate Class III/IV imports at 30.4%.
Malaysia MDA: 2,462 Establishments, 23% Expiry Cliff, J&J at 58% Renewal
Malaysia MDA 49,198-row device dataset reveals 2,462 establishments with top-20 concentration at 18.7% and 11,438 devices expiring by end 2027. Data-driven establishment selection insights.
Mexico COFEPRIS Registration Holders: 5,286 Holders and the 2024 Volume Surge
Analysis of Mexico's 16,473 COFEPRIS registrations reveals 5,286 holders, 60% single-registration, diagnostics dominance at 37%, and a 2024 record peak.
Qatar's 2,623 Implantable Devices: 62% in 20 Suppliers, Lebanese Lock-In
Qatar MoPH implantable device register: 2,623 devices, 171 suppliers, top 20 control 62%. Lebanese distributor dominance and single-supplier manufacturer lock-in analyzed.
Saudi SFDA AR Concentration: 1,608 ARs, 35% in 20 Hands, 13,700 Expiry Cliff
Saudi SFDA 56,737-row device database: 1,608 ARs, top-20 concentration at 35.4%, and 13,717 devices expiring 2026-2027. Data-driven AR selection insights.
UAE EDE: 10 Suppliers Control a Third of All Medical Device Registrations
UAE EDE data shows 10 suppliers control 33.7% of 4,793 medical device registrations. Cigalah, Pharmatrade lead. US tops country of origin at 16%. Dubai holds 63.5% of registrations.
Hong Kong Dermal Filler MDACS Listing Strategy: LRP, Docs, Importers, Procurement
Guide to listing injectable dermal fillers under Hong Kong MDACS after the May 2026 GN-00 update: LRP, technical dossier, importer controls, adverse event reporting, and procurement.
RPM Device Regulatory Pathway: FDA, CMS Reimbursement & EU MDR (2026)
RPM device regulation: FDA classification, CMS 2026 CPT codes (99445, 99470), reimbursement rates, SaMD, EU MDR pathway, and commercialization strategy for connected monitoring devices.
FDA Bone Growth Stimulator Reclassification 2026: Class III to II
Guide to FDA's 2026 reclassification of non-invasive bone growth stimulators from Class III to Class II, including special controls, 510(k) impact, CMS billing updates, and manufacturer implications.
Avanos Medical AIP $1.27B Take-Private: Medtech Deal Analysis
Analysis of AIP's $1.27B Avanos Medical take-private deal, including nutrition and pain management franchises, NOPAIN Act tailwinds, deal terms, and private equity signals for medtech.
Artivion-Endospan $175M Deal: Nexus Aortic Arch System and FDA PMA
Analysis of Artivion's $175M Endospan acquisition after FDA PMA approval, covering the Nexus Aortic Arch System, TRIOMPHE trial data, portfolio fit, and endovascular market impact.
Medtronic SPR Therapeutics Deal: Neuromodulation for Chronic Pain
Analyze Medtronic's $650 million SPR Therapeutics acquisition, including SPRINT PNS technology, clinical evidence, pain therapy strategy, competition, and market impact.
Boston Scientific-MiRus $1.5B TAVR Investment: SIEGEL Valve Strategy
Analysis of Boston Scientific's $1.5B MiRus investment, the SIEGEL balloon-expandable TAVR system, STAR pivotal trial, rhenium alloy technology, and structural heart market implications.
CMS NTAP Repeal for Breakthrough Devices: FY 2027 IPPS Impact
Guide to CMS's proposed repeal of the NTAP alternative pathway, the new RAPID coverage program, commercialization impact, and next steps for device makers.
ASC Expansion 2026: CMS Final Rule and Medtech Commercial Strategy
How the CMS CY 2026 OPPS/ASC Final Rule adds 573 procedures, phases out inpatient-only limits, expands device payment opportunities, and reshapes medtech commercialization.
Best Regulatory Intelligence Software for Medical Devices 2026
Independent comparison of regulatory intelligence software for medical device and IVD teams, covering RegDesk, IQVIA, Cortellis, Obsidian, Basil Systems, ArisGlobal, Freyr, and Veeva.
Kenya Medical Device Registration Guide: PPB Process, Fees and Requirements
Register medical devices in Kenya through the PPB, covering Class A-D classification, evaluation routes, reliance pathways, local representative duties, import permits, QMS audits, and surveillance.
PMDA eCTD v4.0 for Medical Devices: Complete Transition Guide After the April 2026 Mandate
Japan's PMDA made eCTD v4.0 mandatory on April 1, 2026. Learn what changed, Module 1 expectations, device submission issues, and compliance steps.