Commercialization
203 articles
GE HealthCare
A global registry dossier for GE HealthCare, analyzing medical device registrations across 24 non-US markets and regional representative structures.
Morocco AMMPS Medical Device Establishment Teardown: 171 Declared Entities
An analysis of Morocco's AMMPS list of 171 declared medical device establishments, exploring why MNCs enter via local partners and Law 10.22 changes.
Stryker Global Medical Device Registrations Dossier
A global registry dossier for Stryker Corporation, analyzing medical device registrations across 23 non-US markets and the integration of major acquisitions like Howmedica and Wright Medical.
US Medical Device Import Dependence: The $14.5B Trade Deficit
A detailed analysis of US medical device import trade flows from 2013 to 2025, detailing the $14.5B core-device deficit and Section 232 tariff risks.
Zimmer Biomet Global Medical Device Registrations Dossier
A global registry dossier for Zimmer Biomet, analyzing medical device registrations across 24 non-US markets and the integration of Zimmer Holdings and Biomet.
Chile ISP Registered Devices Teardown & Channel Map
A registry analysis of the 619 devices registered under Chile's ISP decree-controlled families, covering condom and syringe category skews, manufacturer countries, and titular concentration.
Oman MOH Registered Devices Teardown & Class C/D Transition
A data teardown of the 502 medicated devices on the Oman MOH register, detailing the dermatology and ophthalmology category skews, local agent concentration, and the new Class C/D mandate.
Pakistan DRAP Registered Medical Devices Teardown & 2025 Ramp
A quantitative analysis of the 12,666 medical devices registered under Pakistan's DRAP, detailing the Class A-D splits, local-vs-import manufacturer mix, and the 2025 registration surge.
Albania AKBPM Medical Device Registry Teardown: Manufacturers & LTRs
A data-driven teardown of Albania's AKBPM register. Analyze the risk-class split, category mix, manufacturer landscape, and distributor concentration.
Kenya PPB Retained Medical Devices Teardown: Manufacturers & LTRs
A data-driven teardown of Kenya's PPB retained medical devices register. Analyze the manufacturer landscape and local technical representative concentration.
Bolivia AGEMED Medical Device Registry Teardown: Weekly Decision Signals
A quantitative analysis of Bolivia's AGEMED weekly registration bulletins: 5,714 decision signals, the high 44% deficiency rate, and importer fragmentation.
Guatemala MSPAS Medical Device Registry Teardown: Database Analysis
A quantitative teardown of Guatemala's MSPAS active-inscriptions list: 26,763 active medtech registrations, IVD-reagent dominance, and the 2026 renewal cohort.
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.
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.