Supply Chain
53 articles
Swissdamed Mandatory July 2026: Swiss Device Registration and UDI Guide
Guide to Switzerland swissdamed mandatory registration from July 1, 2026, covering UDI uploads, Product Module, CH REP duties, M2M, grace periods, and triggers.
EU MDR Importer & Distributor Obligations: Complete Guide to Articles 13, 14, and 16
Guide to EU MDR importer and distributor obligations under Articles 13, 14, and 16, including registration, labeling, QMS duties, checks, and MDCG guidance.
Medical Device Tariffs & Trade War Impact 2026: What Manufacturers Need to Know
Understand how 2026 tariffs, EU-China trade tension, and Mexico tariff changes affect medtech supply chains, with manufacturer impacts and practical mitigation strategies.
Brazil SUS Medical Device Procurement: Public Healthcare System Market Access Guide (2026)
Guide to Brazil SUS medical device procurement, covering Law 14,133/2021, CONITEC health technology assessment, Compras.gov.br e-procurement, foreign supplier requirements, pricing, and market entry.
Germany GKV Medical Device Procurement and Reimbursement Guide 2026
Navigate Germany's GKV procurement and reimbursement system, including G-DRG, NUB, DiGA, Hilfsmittelverzeichnis, tenders, BfArM, and market access.
India Government Medical Device Procurement: GeM, Make in India, Reimbursement
Guide to India's medical device procurement channels, including GeM tenders, Make in India rules, CGHS and PM-JAY reimbursement, CDSCO/BIS requirements, and market access.
Indonesia e-Katalog Medical Device Procurement: JKN, TKDN, Market Access
Guide to Indonesia's e-Katalog procurement system for medical devices, including MoH catalogs, JKN reimbursement, TKDN local content rules, registration, and distributor requirements.
Japan NHI Medical Device Procurement: Reimbursement, Pricing and Market Access
Guide to Japan NHI medical device procurement, covering reimbursement pricing, STM and non-STM categories, DPC bundling, hospital tendering, and foreign supplier market access requirements.
Nigeria Medical Device Procurement Guide: NHIA, Medipool, NAFDAC, and BPP
Guide to Nigeria medical device procurement: NHIA coverage, Medipool GPO purchasing, BPP tenders, NAFDAC registration, BHCPF funding, and supplier strategy.
Saudi Arabia NUPCO Medical Device Procurement and Market Entry Guide
Guide to Saudi Arabia's NUPCO medical device procurement, including framework tenders, SFDA registration, localization requirements, Wasfaty integration, and foreign manufacturer strategy.
Thailand Medical Device Procurement 2026: NHSO, E-Bidding and Market Access
Guide to Thailand medical device procurement via NHSO, Universal Coverage, e-Market, e-Bidding, Thai FDA rules, Innovation List preferences, and market access.
US Government Medical Device Procurement: GPOs, FSS and Market Access
Guide to US public-sector device procurement through GPOs, VA Federal Supply Schedules, DoD channels, GSA contracts and SAM.gov registration.
Medical Device Supply Chain Risk Management and Supplier Quality
Manage medical device supply chain risk with supplier qualification, risk assessment, dual sourcing, quality agreements, FDA and ISO 13485 controls, and resilience planning.