Regulatory
529 articles
Lebanon MoPH Authorized Implantable Medical Devices Teardown
A detailed analysis of Lebanon's Ministry of Public Health implantable medical device register under Decree 455/1, examining risk classes, manufacturers, and supplier dynamics.
Adaptive AI Medical Devices: Why an FDA PCCP Won't Update Your Model in the EU or Japan
A cross-market analysis of AI medical device change control, comparing the US FDA PCCP, Japan's IDATEN framework, and the EU's MDR and AI Act modification rules.
Why FDA or CE Clearances Fail to Register Aesthetic Devices in China, Korea, and Brazil
A deep regulatory analysis of aesthetic device classification and registration pathway divergence across the US, EU, China, South Korea, and Brazil, mapping sequencing strategies and all-in costs.
Bangladesh DGDA Registered Medical Devices Teardown: Chinese IVDs & Class C Majority
A data-driven teardown of Bangladesh's Directorate General of Drug Administration (DGDA) registered medical device list, analyzing risk classes, manufacturers, and importers.
Why One FDA/CE Clearance Opens Far Fewer CGM Markets: The Global Class-Divergence Map
A comprehensive cross-market analysis of continuous glucose monitor (CGM) classification, clinical trial requirements, and reimbursement gates across the US, EU, China, Japan, and Canada.
How to Get FDA to Tell You Which Center Will Regulate Your Product: The Pre-RFD Playbook
A comprehensive regulatory guide to FDA's Pre-Request for Designation (Pre-RFD) process for borderline and combination products under the revised November 2025 guidance.
How Generative AI Now Picks Medical Devices for Hospital Procurement
Discover how Value Analysis Committees and hospital procurement teams use generative AI to source devices, and why off-site evidence footprints dominate AI recommendations.
Ukraine DLS Medical Device Register Teardown: Germany-First Supply Map
A comprehensive data teardown of Ukraine's State Service on Medicines and Drugs Control (DLS) medical device register, analyzing source countries, conformity frameworks, and wartime rules.
Angola ARMED Healthcare Establishment Teardown: 3,692 Licensed Operators
A quantitative teardown of Angola's ARMED registry of 3,692 licensed healthcare establishments, analyzing the importer-distributor split and Luanda's logistics dominance.
Cuba CECMED Medical Device Registry Teardown: 4,739 Registrations
A quantitative teardown of Cuba's CECMED medical device registry of 4,739 approved registrations, analyzing the mix of global suppliers, local biotech institutes, and clinical specialties.
Ivory Coast AIRP Medtech Importer Teardown: 658 Approved Wholesalers
A quantitative teardown of Côte d'Ivoire's AIRP registry of 658 approved medtech establishments, analyzing the hyper-concentration in Abidjan and WAEMU market-access routes.
NIH SBIR/STTR Medical Device Funding Teardown: Winners and the Phase I to II Funnel
A deep dive into $2.97B in NIH SBIR/STTR medical device R&D grants. Analyze Phase I vs Phase II funding, repeat winners, geographic hubs, and grant strategy.
The US Public Medical Device Company Universe by SEC SIC Code and State
A structural analysis of 1,273 SEC-registered medtech companies by SIC sector and state. Explore industry clustering, sector-value asymmetry, and geographic opportunity corridors.
Continuous Glucose Monitor FDA Recalls & MAUDE: Dexcom & Abbott Teardown
An in-depth analysis of continuous glucose monitor (CGM) recalls and MAUDE safety data, comparing Dexcom and Abbott sensor, receiver, and software failures.
CT, MRI & Fluoroscopy FDA Recalls: Siemens, Philips & GE Teardown
A safety teardown of CT, MRI, and fluoroscopy recalls. We review Siemens, Philips, and GE recall volumes, magnet venting risks, and cybersecurity issues.
FDA Medical Device Product Codes: Analysis of 7,075 Classification Codes
A data-driven analysis of the FDA Medical Device Classification Database. We parse 7,075 product codes by class, specialty panel, and submission type.
FDA Anesthesia Machine Recalls: GE, Dräger & Getinge MAUDE Teardown
A manufacturer-spanning teardown of FDA anesthesia system recalls and MAUDE adverse events, analyzing GE Carestation, Dräger Atlan, and Getinge Flow.
FDA Heart Valve Recalls: Edwards, Medtronic & Abbott MAUDE Teardown
A manufacturer-spanning teardown of FDA heart valve recalls and MAUDE database adverse events, analyzing Class I events and common failure modes.
FDA OTC Hearing Aid Regulation: Product Codes & MAUDE Adverse Events
A comprehensive B2B regulatory guide to the FDA OTC hearing aid framework. Details product codes, 510(k) exemptions, conditions for sale, and MAUDE data.
Disposable Circumcision Devices: FDA 510(k) Pathways & Clinical Evidence
An in-depth regulatory and clinical analysis of disposable circumcision devices (staplers, clamps, and rings), detailing FDA product codes, clinical trials, and market entry due diligence.