MedDeviceGuide — IVD & Medical Device Knowledge Base

Guide to South Africa SAHPRA medical device registration in 2026, covering establishment licensing, Class A-D classification, ISO 13485, reliance pathways, fees, and AR duties.

Guide to Taiwan TFDA device registration in 2026, covering Medical Devices Act rules, Class I-III classification, QSD, local agents, UDI, fees, and timelines.

Turkey medical device registration guide for 2026, covering TITCK rules, EU MDR/IVDR alignment, UTS registration, representative duties, fees, and timelines.

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.

Learn how the EU AI Act applies to AI-enabled medical devices, including high-risk classification, MDR/IVDR overlap, conformity assessment, and 2026 deadlines.

Data-driven guide to FDA 510(k) clearance rates, RTA holds, NSE decisions, common failure reasons, and practical strategies to improve first-cycle clearance in 2026.

Navigate Germany's GKV procurement and reimbursement system, including G-DRG, NUB, DiGA, Hilfsmittelverzeichnis, tenders, BfArM, and market access.

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.

Guide to Indonesia's e-Katalog procurement system for medical devices, including MoH catalogs, JKN reimbursement, TKDN local content rules, registration, and distributor requirements.

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.

Benchmark medical device regulatory consulting rates by region and consultant tier, with cost drivers and budgeting guidance for registration projects in major markets.

Guide to Nigeria medical device procurement: NHIA coverage, Medipool GPO purchasing, BPP tenders, NAFDAC registration, BHCPF funding, and supplier strategy.

Guide to Saudi Arabia's NUPCO medical device procurement, including framework tenders, SFDA registration, localization requirements, Wasfaty integration, and foreign manufacturer strategy.

Guide to South Korea medical device procurement and reimbursement, covering MFDS approval, HIRA listing, NECA HTA, Immediate Market Entry, pricing, and foreign manufacturer strategy.

Guide to Thailand medical device procurement via NHSO, Universal Coverage, e-Market, e-Bidding, Thai FDA rules, Innovation List preferences, and market access.

Guide to US public-sector device procurement through GPOs, VA Federal Supply Schedules, DoD channels, GSA contracts and SAM.gov registration.

Guide to ASEAN AMDD and CSDT requirements in 2026, including Class A-D classification, dossier sections, member state implementation, reliance pathways, fees, timelines, and market entry.

Guide to BIS certification for medical devices in India, covering required standards, ISI marking, testing, Manakonline, CDSCO overlap, timelines, and costs.

Guide to using real-world evidence and real-world data in medical device submissions, including FDA guidance, data sources, reliability criteria, and regulatory strategy.

ANMAT medical device registration guide covering Argentina classification, Declaration of Conformity and full review routes, HELENA submissions, fees, timelines, local representative duties, and GMP.