Vietnam
3 articles
Vietnam Medical Device Registration Cost 2026: Authorized Representative (AR/MAH) Pricing Models, Flat Fee vs Hourly, 3-Year Cash Flow
How much does it cost to register a medical device in Vietnam in 2026? A buyer-side breakdown of Vietnam Authorized Representative / Marketing Authorization Holder service pricing — hourly billing, registration-fee-plus-annual, and flat all-inclusive fee — with worked 3-year cash flow scenarios for Class A/B notifications and Class C/D registrations under Decree 98/2021 and Decree 07/2025.
ASEAN Medical Device Entry: The 6-Country Matrix for Distributor Qualifications and FDA/NMPA Test Report Reuse
A reference matrix answering two questions not covered in any existing ASEAN guide: what specific licenses, QMS certifications, warehouse infrastructure, and pharmacovigilance setup must your distributor hold in each of the 6 major ASEAN markets, and which countries accept FDA or NMPA test reports without full retest.
Vietnam Medical Device Registration Guide (2026): Complete Process, Fees, Timeline & Requirements
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.