Regulatory
567 articles
Turkey TİTCK ÜTS Medical Device Registry Teardown: Database Analysis
A quantitative teardown of Turkey's TİTCK ÜTS national medical device register: 5.78M records, domestic-vs-import split, risk-class distribution, and the 1-in-5 rejection rate.
Kazakhstan Medical Device Registry Teardown: NDDA Database Analysis
A quantitative teardown of Kazakhstan's NDDA State Register: 32,117 total registrations (14,048 active), EAEU risk class split, and clinical areas.
Moldova Medical Device Registry Teardown: AMDM Database Analysis
A data-driven teardown of Moldova's AMDM Register of Medical Devices: 20,339 records, country-of-origin share (China leads with 36.9%), and top authorized representatives.
Paraguay Medical Device Registry Teardown: DINAVISA Database Analysis
A quantitative analysis of Paraguay's DINAVISA medical device registro sanitario database: 8,162 registrations, product-type split, and leading holders.
Ecuador ARCSA Medical Device Register Analysis: 326,334 Records
A data-driven teardown of Ecuador's ARCSA medical device registro sanitario: 326,334 listed records, 22,056 registrations, risk classes I-IV, device types, and titular concentration.
Montenegro CINMED Medical Device Register Analysis: 15,179 Records
A data-driven teardown of Montenegro's CINMED Register of Medical Devices: 15,179 records, EU-aligned risk classes, IVD share, product categories, and local-holder concentration.
Serbia ALIMS Medical Device Register Analysis: 57,153 Records
A data-driven teardown of Serbia's ALIMS Register of Medical Devices: 57,153 records, EU-aligned risk classes, IVD share, country-of-origin, and authorized-representative concentration.
Medical Device Cybersecurity Compared: FDA §524B vs EU MDR/MDCG/CRA
A comprehensive regulatory comparison of medical device cybersecurity requirements under US FDA Section 524B and the EU MDR, MDCG 2019-16, and Cyber Resilience Act (CRA).
Myanmar Medical Device Directory: FDA Registrations & Distributors
A quantitative analysis of the Myanmar FDA medical device registry, detailing manufacturer country-of-origin distributions, top local distributors, and registration pathways.
North Macedonia Medical Device Registry: MALMED Teardown & Analysis
A comprehensive analysis of North Macedonia's MALMED medical device register, detailing risk classifications, product categories, and local registrant landscapes.
El Salvador DNM Medical Device Registry: 21,607 Approvals & Importer Dynamics
An in-depth analysis of El Salvador's medical device registry (DNM/SRS). Understand active vs. cancelled ratios, risk classes, and top local importers.
Ethiopia Medical Device Registry: 5,915 Approvals & Local Dynamics
A comprehensive teardown of the Ethiopian Food and Drug Authority (EFDA) eRIS database. Review manufacturer origins, top local importers, and regulatory steps.
Mindray Worldwide Market-Access Footprint: 24-Market Registry Teardown
A comprehensive database analysis detailing Mindray's 6,620 distinct registrations across 24 global markets, including patient monitoring accessories, IVD, and ultrasound segments.
Philips Worldwide Regulatory and Safety Footprint: 26-Market Registry Teardown
A comprehensive database analysis detailing Philips' 7,909 distinct registrations across 26 global markets, integrated with clinical trial data and patent portfolios.
Siemens Healthineers Global Regulatory Footprint: 28-Market Registry Breakdown
A comprehensive database analysis detailing Siemens Healthineers' 18,956 distinct registrations across 28 global markets, including IVD, imaging, and oncology segments.
Uzbekistan Medical Device Registry: 6,572 Approvals & Entry Trends
A data-driven analysis of Uzbekistan's Uzpharm State Register. Discover registration volumes, product categories, and leading foreign suppliers.
China NMPA Device Registration: 14,187 Approvals, Import Mix, and Foreign Wins
A data-driven analysis of China's NMPA medical device registry database. Discover approval volumes, import vs. domestic splits, and strategic pathways for foreign device makers.
FDA Insulin Pump Recalls: Medtronic, Insulet, and Tandem — A MAUDE and Class I Teardown
A comprehensive regulatory and clinical engineering teardown of FDA insulin pump recalls. Analyze manufacturer volumes, mechanical root causes, and MAUDE safety trends.
Philips CPAP Recall: PE-PUR Foam, 15 Million Devices, 561 Deaths Teardown
A detailed regulatory and quality system teardown of the Philips Respironics CPAP recall. Understand PE-PUR foam chemistry, the FDA consent decree, and MDR metrics.
Abbott FDA Device Footprint: Diagnostics, Recalls & PMA Portfolio
A data-driven regulatory profile of Abbott's FDA clearances, PMA approvals, safety recalls, diagnostics division, and global manufacturing hubs in Illinois, California, Germany, and the Netherlands.