MedDeviceGuideMedDeviceGuide
Topic

Supply Chain

53 articles

Labeling & UDI

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 / IVDR

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.

Industry News

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.

Reimbursement & Market Access

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.

Reimbursement & Market Access

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.

Reimbursement & 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.

Reimbursement & 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.

Reimbursement & Market Access

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.

Reimbursement & Market Access

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.

Reimbursement & Market Access

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.

Reimbursement & Market Access

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.

Reimbursement & 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.

Supply Chain

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.