MedDeviceGuide — IVD & Medical Device Knowledge Base
Saudi Arabia SFDA Registered Devices Teardown & Channel Map
A database teardown of the 163,185 medical devices registered under Saudi Arabia's SFDA, detailing MDMA risk class splits, manufacturer concentration, and AR lock-in risks.
Algeria MIPH Medical Device Import Teardown: 327 Approved Importers
A quantitative teardown of Algeria's MIPH list of 327 approved medical device importers, analyzing the SARL-dominated legal mix and Decree 24/22 reforms.
BD (Becton, Dickinson) Global Medical Device Registrations Dossier
A global registry dossier for Becton, Dickinson and Company (BD), analyzing medical device registrations across 25 non-US markets and the integration of CareFusion and C.R. Bard.
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.
Zambia ZAMRA Medical Device Registry Teardown: Manufacturers & LTRs
A data-driven teardown of Zambia's ZAMRA medical device and IVD registry. Explore risk-class splits, country of origin trends, and LRP channel 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.
China Medical Device Distributor and CSO Compliance Audit Checklist
Operational audit checklist for China medtech distributors, CSOs, and clinical application specialists to meet hospital reception and anti-bribery standards.
China Medical Device Sales Representative Compliance: 2026 Guide
Will China's 2026 Medical Representative Management Measures apply to medtech field teams? Learn how device and IVD firms should prepare for upcoming rules.
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.