Regulatory
408 articles
FDA Class I Device Recalls: 3,510 Events, Firms, and Trends Since 2006
3,510 FDA Class I device recalls since 2006, led by Medtronic, Boston Scientific and Teleflex. Catheters and ventilation devices drive a sharp post-2020 rise.
FDA MAUDE Trends 2020–2025: 14.4M Reports, Diabetes Dominance, Rising Deaths
Analysis of 14.4M FDA MAUDE adverse event reports (2020–2025) shows diabetes devices account for over half of all events. Death reports rose 63% from 2020 to 2024.
Singapore HSA Registry: 20,600 Devices, Ownership, and Registrant Concentration
Analysis of Singapore's medical device register shows 20,599 approved devices across 859 registrants. Top 20 registrants hold 35.5%, while US product owners hold 37.9% of all devices.
EU AI Act for Medical Devices: August 2028 Deadline and MDR Dual Compliance Strategy
EU AI Act Omnibus extends medical device AI compliance to August 2, 2028. Dual MDR strategy, data governance, human oversight, tech doc integration, and preparation timeline.
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.
Who Clears the Most FDA 510(k) Devices? 175K Records by Country and Applicant
Analysis of 175,149 FDA 510(k) clearances shows foreign applicants exceed US ones since 2021. China leads non-US at 19.1%, top 50 applicants hold under 10%.
Global Device Manufacturing Map: 24,795 FDA-Registered Establishments
FDA establishment data shows 59.7% of 24,795 registered facilities are foreign. China leads with 4,753 establishments and contract manufacturing dominates.
UDI Database Decoded: 5.08M Records Show Orthopedic Dominance, Concentration
Analysis of 5.08 million FDA GUDID records shows orthopedic devices lead at 49.6%, Cardinal Health and Medline hold 12.4% of a 10K-record sample, and Class II devices dominate at 85.3%.
FDA Medical Device Recalls Decoded: 58K Records, Root Causes, and Trends
Analysis of 58,374 FDA device recalls shows 85.8% are Class II, device design is the leading identified root cause at 13.0%, and annual recall volume peaked at 3,313 in 2017.
PMA Class III Landscape: 56,508 Records Show Cardiovascular Dominance
56,508 PMA records show cardiovascular dominates at 50.8%, top 5 applicants hold 31.5%, and the average PMA accumulates 34.5 supplements.
India's Medical Device Market Decoded: 4,108 Manufacturers, 62% Imports
India's medical device market reached $20.98B in 2026 with 4,108 licensed manufacturers. Class A and B devices dominate at 76%, while imports supply 62% of market demand.
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 MDR Post-Market Surveillance Plan: MDCG 2025-10 Practical Guide
Build a PMS plan aligned with MDCG 2025-10 guidance: proactive data collection, QMS integration, trend reporting, PMS reports vs PSURs, and custom-made device obligations.
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.
Medical Device Accessory Classification: EU MDR and FDA Pathways
How accessories are classified separately from parent devices under EU MDR Article 2(2) and FDA 513(f)(6), with examples, MDCG 2021-24 Rev.1 updates, and FDA's 2025-2026 reclassification initiative.
Aesthetic Device Regulation: FDA 510(k) and EU MDR for Laser, RF, and Energy Devices
How energy-based aesthetic devices — laser, RF, HIFU, IPL, cryolipolysis, and EMS — are classified and cleared by FDA and EU MDR, including special controls, Annex XVI, and 2026 compliance updates.
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.
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.