Market
Vietnam
4 articles
Regulatory
Vietnam MOH Device Register: 108,600 Valid Registrations and a 3× Decree 98 Surge
Vietnam's MOH register holds 108,658 valid registrations across 21,871 applicants; new filings tripled in 2022 under Decree 98. Highly fragmented (HHI 16).
11 min read2026-06-13
›Reimbursement & Market Access
Vietnam Medical Device Registration Cost 2026: AR/MAH Pricing Guide
Buyer-side guide to Vietnam AR/MAH service pricing, flat fees versus hourly billing, and 3-year cash flow scenarios for Class A-D registrations.
41 min read2026-04-24
›Reimbursement & Market Access
ASEAN Device Entry: Distributor Qualification and Test Report Reuse Matrix
Six-country ASEAN matrix covering distributor licenses, QMS and warehouse requirements, vigilance setup, and where FDA or NMPA test reports may reduce retesting.
16 min read2026-04-10
›Regulatory
Vietnam Medical Device Registration Guide 2026: Process, Fees and Timeline
Step-by-step guide to Vietnam medical device registration, covering Decree 98, Class A-D pathways, CSDT requirements, fees, timelines and local representative duties.
13 min read2026-04-04
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