Regulatory
408 articles
FDA Surgical Mesh Recalls: 171 Actions and the Polymeric-Mesh MAUDE Record
Surgical mesh analysis: 171 FDA recalls, 15 Class II enforcements, and 145,000 MAUDE reports. Bard/Davol leads recalls and reports; the POP-mesh 510(k) line was pulled to Class III in 2016.
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.
Hemodialysis Recalls: 821 Events Show the Burden Sits in Disposables, Not Machines
FDA hemodialysis recall analysis: 821 events across 26 dialysis codes — 96.6% in disposables and catheters, not machines. 82 Class I actions; Fresenius and Baxter lead.
Home Oxygen Concentrator Recalls: 44 FDA CAW Records and 11 Class I Actions
Home oxygen concentrator CAW recall analysis: 44 FDA recall records; 33 have enforcement classifications, including 11 Class I. Nidek leads the Class I fire record across 52,664 MAUDE reports.
FDA Infusion Pump Recalls: 1,180 Events and the Class I Software-and-Alarm Causes
FDA infusion pump recall analysis: 1,180 events, 189 Class I actions. Software and alarm defects dominate the most serious recalls, led by BD, Baxter, and ICU Medical.
Pulse Oximeter 510(k) Map: 726 Predicate Clearances and the FDA Pigmentation Reckoning
Pulse oximeter 510(k) analysis: all 726 DQA clearances are predicate-based, led by Masimo, Nonin, and Nellcor. FDA's 2025 draft guidance targets skin-tone accuracy bias.
FDA Surgical Stapler Recalls: 19 Class I Actions and the Misfire-and-Fragmentation Record
FDA surgical stapler analysis: 222 enforcement actions, 19 Class I recalls. Ethicon dominates the most-serious actions; malformation, misfire, and fragmentation lead, across 31,000 MAUDE reports.
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.
510(k)-Exempt in 2026: How to Check the QMSR, Registration, and UDI Duties You Owe
A 510(k) exemption removes one filing, not your compliance program. How to confirm exempt status and the QMSR, registration, and UDI duties that survive.
FDA Establishment Registration Lookup: Manufacturer, Importer, and US Agent Roles
How to read an FDA establishment registration to identify manufacturer, contract manufacturer, importer, and US agent roles — with role-count data.
GUDID Data-Quality Checklist: What Distributors Should Verify Before a Contract
A portfolio GUDID data-quality checklist for distributors — check labeler completeness, missing descriptions, and identifier integrity per contract.
How to Check if a Medical Device Was Recalled: FDA Recall Database Lookup
How to search the FDA recall database and Enforcement Reports to check if a device was recalled, what Class I/II/III means, and how to read a recall status — with data on recall volume and classes.
How to Verify a Medical Device UDI: A GUDID Lookup Workflow for Hospital Purchasing
How to look up and verify a medical device's UDI in FDA AccessGUDID before purchasing, what the DI fields mean, and the data-quality gaps that break a lookup.
Israel MOH Device Register: 28,800 Devices, 92% Imports, and Importer Concentration
Israel's MOH register lists 28,821 medical devices — 91.8% imported, the US/Germany/China supply 53.6%, and 2,111 importers (IRHs) hold the licence layer.
Japan PMDA Device Landscape: 88,900 Approved Products and MAH Concentration
Japan's PMDA database lists ~88,900 approved medical devices held by 2,796 MAHs; the top 50 MAHs hold 40.8%, and a 2021 cluster reflects the e-IFU/UDI mandate.
PMA Supplement Types Explained: 180-Day, Panel-Track, Real-Time, 30-Day, and Special
How to choose the right PMA supplement type under 21 CFR 814.39 — 180-day, panel-track, real-time, 30-day notice, and special — with data on what changes actually drive supplements.
Vietnam MOH Device Register: 108,600 Valid Registrations and a 3× Decree 98 Surge
Vietnam's MOH register holds 108,658 valid registrations across 21,871 applicants; new filings tripled in 2022 under Decree 98. Highly fragmented (HHI 16).
Taiwan TFDA Registry: 52,726 Devices, Import Dependence, and Applicant Concentration
Analysis of Taiwan's TFDA medical device register shows 52,726 active devices. 74.1% are imported (US 22.6%, Germany 9.5%), Class II dominates at 52.9%, and top 10 applicants hold 14.5%.
UK MHRA Device Register: 22,554 Devices, UK Manufacturing Base & Post-Brexit Registration
Analysis of the UK MHRA device register shows 22,554 registered devices. UK manufacturers hold 33.5%, IVD accounts for 37.7%, and the top 10 manufacturers hold 13.1% of registrations.