Reimbursement & Market Access

Learn how dual CE Mark and FDA 510(k)/PMA approval expands access across 25+ markets, speeds reliance registrations, and improves market-entry leverage.

See where CE marking supports device approvals across 25+ markets, including full reliance, abridged review, evidence acceptance, and remaining local steps.

Clarifies when Indonesian medical devices need BPJPH Halal certification, how AKD registration works, and why CDAKB obligations usually sit with local distributors.

Operational guide to transferring a Saudi SFDA MDMA authorized representative, covering process steps, 2026 fees, multi-AR rules, and escalation when the outgoing AR will not cooperate.

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.

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.

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.

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