Reimbursement & Market Access

Compare medical device registration in Brazil, Mexico, Colombia, Argentina, Chile, and Peru, including classification, timelines, fees, local reps, pathways, and 2026 updates.

Register and commercialize medical devices in France with EU MDR, ANSM, EUDAMED, French labeling, LPPR reimbursement, CNEDiMTS, and CEPS requirements.

Market medical devices in Germany with EU MDR, BfArM, PEI, MPDG, EUDAMED, DMIDS, German labeling, clinical investigations, and DiGA strategy.

Guide to Israel AMAR medical device registration in 2026, including classification, declaration and fast-track routes, IRH duties, approvals, SII, and labeling.

Guide to Italy medical device market access in 2026, including EU MDR, BD/RDM Repertorio registration, EUDAMED deadlines, Italian labeling, and HTA.

Guide to Malaysia MDA medical device registration in 2026, covering Class A-D classification, CAB assessment, MeDC@St submissions, Singapore reliance, authorized representatives, fees, and timelines.

Register and market devices in the Netherlands under EU MDR, including IGJ oversight, CIBG Farmatec, NOTIS, Dutch labeling, EUDAMED, CCMO trials, notified bodies, and PMS.

Register medical devices in the Philippines with PFDA/CDRRHR classification, CMDN and CMDR pathways, LTO requirements, ASEAN AMDD alignment, fees, and submission steps.

Guide to Singapore HSA medical device registration in 2026, covering Class A-D classification, evaluation routes, CSDT requirements, fees, and SHARE submissions.

Guide to marketing medical devices in Spain in 2026, covering EU MDR, AEMPS registration, Royal Decree 192/2023, EUDAMED deadlines, Spanish labeling, and regional notifications.

Guide to Thailand medical device registration, Thai FDA Class 1-4 rules, CSDT, licensing, e-Submission, THB fees, auto-approval, and importer duties.

Step-by-step guide to Vietnam medical device registration, covering Decree 98, Class A-D pathways, CSDT requirements, fees, timelines and local representative duties.

Guide to EU Authorized Representative requirements under MDR and IVDR, including Article 11 mandates, PRRC duties, EUDAMED registration, costs, and selection.

Navigate Japan's medical device approval system — PMDA pathways, QMS requirements, MAH structure, clinical trials, reimbursement, and practical market entry guidance.

Navigate South Korea's medical device regulatory system — MFDS classification, KGMP, approval pathways, clinical requirements, and practical market entry guidance.

How medical devices get reimbursed — coding systems, CMS coverage pathways, private payer strategy, health technology assessment, and building a reimbursement strategy from day one.