Reimbursement & Market Access

A comprehensive comparison of medical device registration requirements across Latin America's six major markets — Brazil (ANVISA), Mexico (COFEPRIS), Colombia (INVIMA), Argentina (ANMAT), Chile (ISP), and Peru (DIGEMID) — covering classification, timelines, fees, pathways, and 2026 regulatory updates.

Everything you need to know about marketing medical devices in France in 2026 — including EU MDR requirements, ANSM registration, EUDAMED deadlines, French-language labeling mandates, CNEDiMTS and CEPS reimbursement pathway, LPPR listing, clinical investigation procedures, materiovigilance obligations, and practical market entry guidance for Europe's second-largest medical device market.

Everything you need to know about marketing medical devices in Germany in 2026 — including EU MDR requirements, BfArM and PEI responsibilities, MPDG national law, German-language labeling mandates, DMIDS and EUDAMED registration, clinical investigation procedures, DiGA digital health pathway, and practical market entry guidance for Europe's largest medical device market.

Everything you need to know about registering medical devices in Israel in 2026 — including AMAR classification, declaration and fast-track routes, Israel Registration Holder (IRH) requirements, reference country approvals, SII certification, labeling in Hebrew, Arabic, and English, and step-by-step registration instructions.

Everything you need to know about marketing medical devices in Italy in 2026 — including EU MDR requirements, Ministry of Health national registration via BD/RDM (Repertorio) database, EUDAMED deadlines, Italian-language labeling mandates, national HTA program (PNHTA-DM), clinical investigation procedures, post-market surveillance, and practical market entry guidance for Europe's fourth-largest medical device market.

Everything you need to know about registering medical devices in Malaysia in 2026 — including MDA classification (Class A–D), CAB conformity assessment, MeDC@St submissions, verification pathway, Singapore reliance route, authorized representative requirements, fees in RM, and step-by-step registration instructions.

Everything you need to know about marketing medical devices in the Netherlands in 2026 — including EU MDR requirements, IGJ oversight, CIBG Farmatec and NOTIS national registration, Dutch-language labeling mandates, EUDAMED deadlines, clinical investigation procedures via CCMO, post-market surveillance, Dutch notified bodies (BSI, DEKRA, Kiwa), and practical market entry guidance for one of Europe's most important medical device hubs.

Everything you need to know about registering medical devices in the Philippines in 2026 — including PFDA/CDRRHR classification (Class A–D), CMDN vs CMDR pathways, ASEAN AMDD alignment, LTO requirements, English-language submissions, fees in PHP, and step-by-step registration instructions.

Everything you need to know about registering medical devices in Singapore in 2026 — including HSA classification (Class A–D), evaluation routes (Immediate, Abridged, Expedited, Full, Priority Review), CSDT requirements, dealer's licence obligations, SHARE portal submissions, fees in SGD, and step-by-step registration instructions.

Everything you need to know about marketing medical devices in Spain in 2026 — including EU MDR requirements, AEMPS national registration database, Royal Decree 192/2023, EUDAMED deadlines, Spanish-language labeling mandates, clinical investigation procedures, post-market surveillance, autonomous region distributor notifications, and practical market entry guidance for one of Europe's largest healthcare markets.

Everything you need to know about registering medical devices in Thailand in 2026 — including Thai FDA classification (Class 1–4), CSDT requirements, establishment licensing, e-Submission system, fees in THB, auto-approval for Class 1, Medical Device Act B.E. 2551, local importer obligations, and step-by-step registration instructions.

Everything you need to know about registering medical devices in Vietnam in 2026 — including MFDS/MOH requirements, Decree 98/2021, classification (Class A–D), fast-track pathways, 50% fee reduction, CSDT requirements, local representative obligations, and step-by-step registration instructions.

A comprehensive guide to EU Authorized Representative (EC REP) requirements under EU MDR and IVDR. Covers Article 11 obligations, mandate requirements, costs, PRRC obligations, EUDAMED registration, and how to select the right EU AR for your medical device or IVD company.

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.