MedDeviceGuide — IVD & Medical Device Knowledge Base
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.
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.
FDA QMSR Remediation Mandate: Pre-2026 Findings Now Require ISO 13485
IsoTis and Longhorn warning letters set FDA precedent: pre-QMSR corrective actions must now meet ISO 13485. Internal audit exposure, risk citations, and prep steps.