Reimbursement & Market Access
113 articles
Jordan JFDA Medical Device Registry Analysis: Importer Concentration
A comprehensive, data-driven analysis of the Jordan Food and Drug Administration (JFDA) medical device registry. Analyze applicant volumes, major distributors, and warehouse allocations.
Nigeria NAFDAC Greenbook Medical Device Registry: Licenses & Expiry Cycles
A comprehensive, data-driven analysis of the Nigeria NAFDAC Greenbook medical device registry. Explore active vs. inactive license ratios, top applicants, and the 5-year renewal cycle.
Tanzania TMDA Medical Device Registry Analysis: Data-Driven Market Insights
A data-driven analysis of the Tanzania TMDA medical device registry: registered vs. notified device ratios, top Local Technical Representatives (LTRs), and source countries.
Thailand FDA Medical Device Database Analysis: 43,337 Records
A comprehensive analysis of 43,337 medical device records in the Thailand FDA database, exploring active vs expired licenses, imported share, and top manufacturers.
Ecuador ARCSA Audit: 3,939 Expired Licenses Highlight Risks Under Resolution 2026-003
An empirical audit of 3,939 expired registrations in Ecuador. Learn how to manage transition compliance risks under the new ARCSA Resolution 2026-003-DASP.
South Korea MFDS Registry: Risk Class, Imports, and Sponsor Concentration
A data-driven analysis of South Korea's MFDS medical device registry. Explore risk class distributions, import vs. domestic splits, and leading sponsors.
Medical Device Economic Operator Duties Compared: EU MDR, NZ, Singapore, Canada, SFDA
Compare sponsor, importer, distributor and authorized-representative duties across EU MDR Articles 11-16, New Zealand WAND, Singapore HPA, Canada MDEL and Saudi SFDA MDS-REQ 9.
Argentina ANMAT: Medical Device Registrations Surged 43× Since 2017
23,060-record ANMAT analysis: Argentina medical device registrations surged 43× from 2017 to 6,237 in 2025. Class I–II dominates; imaging and IVD lead the most-registered categories.
FDA 510(k) by Medical Specialty: 8 Panels Control 68% of All Clearances
175,149 FDA 510(k) clearances analyzed by medical specialty: the top 8 panels control 68%, Cardiovascular leads all-time, and Radiology is the fastest-growing as imaging AI reshapes the mix.
Hong Kong MDD: 20 Local Responsible Persons Hold 44% of 13,049 Device Listings
13,049-record Hong Kong MDACS analysis: US-made devices lead at ~28%, the top 20 LRPs hold 44% of listings, and 2025 saw a record 4,981 listings before mandatory procurement rules.
Colombia INVIMA: 4,582 Importers, 80% Imports — Who Controls Device Access?
Analysis of 423,394 INVIMA records reveals 4,582 importers and 2,537 apoderados competing in Colombia's USD 1.5B device market, with 81.8% of registrations tied to import pathways.
EU-Switzerland MRA Update 2026: What It Means for Medical Device Market Access
How the EU-Switzerland MRA signed March 2, 2026 restores medical device mutual recognition, what changes for EU and Swiss manufacturers, swissdamed timelines, and the path to ratification.
EUDAMED at Scale: 1.29 Million UDI-DIs Reveal Who Supplies the EU Device Market
Analysis of 1,292,737 EUDAMED UDI-DI records shows China leads with 19.1% of registrations, Turkey contributes 10.3% Class III devices, and four countries supply nearly half the EU market.
Indonesia's Device Registry: 78K Registrations, 76% Imported, Expiry Cliff
Analysis of Indonesia's Kemenkes device registry reveals 75.8% of registrations are imports (AKL), China supplies 36.5% of imported devices, and 17.2% of all registrations expire in 2026.
Asia-Pacific Medical Device Registration: Market Comparison and Entry Strategy (2026)
Compare medical device registration across APAC markets — China, Japan, South Korea, Australia, Singapore, India, ASEAN — including timelines, fees, reliance pathways, and strategic entry order.
Medical Device Post-Approval Change Management: FDA, EU MDR, and Asian Markets (2026)
When device modifications require new regulatory submissions in the US, EU, Korea, Japan, and China — FDA special 510(k), PMA supplements, EU MDR significant changes, and Asian pathways.
Veterinary Medical Device Regulation: FDA CVM, EU Gaps, and Global Strategy
How veterinary medical devices are regulated under FDA CVM, EU frameworks, and key global markets. Covers classification gaps, 510(k) exemptions, off-label use, and market entry strategy.
MedTech M&A Market Analysis H1 2026: Deal Trends, Strategic Shifts, and Outlook
Medical device M&A H1 2026: $26.6B Q1 deal value, 87% strategic buyers, Boston Scientific-Penumbra, Danaher-Masimo, portfolio reshaping trends, and H2 outlook for medtech dealmaking.
UK MHRA International Reliance Pathway: Draft Regulations 2026 Analysis
MHRA's draft Medical Devices Regulations 2026: International Reliance Pathway for US, Canada, and Australia approvals, IVD reclassification, PCCPs for AI software, and what manufacturers must prepare.
Australia ARTG Sponsor Map: Who Controls Market Access for 63,000 Devices?
Analysis of Australia's ARTG reveals 3,377 sponsors managing 63,131 device listings — top 10 sponsors control 22%, and Emergo Australia represents 375 overseas manufacturers.