We handle the entire regulatory pathway—from classification and technical pre-audits to consular legalization and official MOH submission. Secure your product registration numbers with 100% compliance security.
Unlike competitors who spread across dozens of countries, MedPass focuses exclusively on Vietnam — giving you unmatched depth of expertise and local connections.
Deep Local Expertise — Our team is based in Vietnam with direct relationships at the Ministry of Health and regulatory bodies.
End-to-End Service — From classification to license approval, we handle every step of the registration process.
Bilingual Team — Fluent in both English and Vietnamese, eliminating communication barriers.
Everything you need to bring your medical devices to the Vietnamese market.
"I want to sell my medical device in Vietnam but don't know where to start."
We figure out the fastest, most cost-effective regulatory pathway for your device. We handle classification, strategy, and everything needed before the paperwork begins.
"I need my product approved — Class A, B, C, or D."
We prepare, submit, and manage the entire registration dossier. From document gathering to consular legalization to submission — you get the license, we handle the complexity.
"My device is approved. Now I need to actually bring it into the country."
We handle import permits, customs requirements, and distribution setup so your product physically reaches the Vietnamese market without delays.
"I need someone in Vietnam to act on my behalf."
We serve as your in-country authorized representative — the local face, the local voice, the local expert handling authorities and obligations so you don't need a Vietnam office.
"I already have a license but I don't want to lose it."
We manage renewals, amendments, regulatory changes, post-market obligations, and anything that could put your license at risk. You focus on selling; we focus on protecting.
"I have questions. I need a regulatory partner I can call."
Ongoing advisory for companies already in the market. New regulations, inspections, label changes, competitor intelligence — we're your Vietnamese regulatory team on retainer.
Search live medical device registrations, check compliance status, and track competitors across Vietnam's official Ministry of Health database.
Our automated systems index more than 80,000 official Vietnam Ministry of Health registration numbers. We can compile deep-dive market share data exports and competitor intelligence reports customized for your business category.
Your journey from inquiry to license in 6 clear steps
We analyze your device specifications to determine the optimal, lowest-risk MOH pathway
We audit your technical documents to resolve any formatting issues before they cause MOH rejections
Our local team manages translations, notarizations, and legalization requirements in Vietnam
We construct and submit your complete dossier via the official Ministry of Health digital portal
We represent your interest directly in Hanoi, defending queries and pushing for rapid administrative sign-off
Receive your active registration numbers and start importing legally with your chosen distributors
Our Vietnam-only focus means unparalleled expertise and results.
While competitors juggle dozens of countries, we dedicate all our resources to mastering Vietnam's regulatory landscape.
Direct connections with MOH officials and regulatory bodies ensure smoother, faster approvals for your devices.
Our deep knowledge of local procedures means we can often cut registration timelines by 30-40%.
Real-time status updates on your application. You always know exactly where things stand.
Understanding the classification system is key to a successful registration strategy.
Basic instruments like tongue depressors & surgical retractors. Self-declaration pathway with simplified documentation.
Devices like hypodermic needles & powered wheelchairs. Requires registration number from the MOH.
Implants, heart valves, and Class D IVDs. Full technical dossier review and clinical evidence required.
A highly specialized alliance of legal, consulting, and medical leaders driving successful medical market entries in Vietnam.
Expert Vietnamese legal counsel specializing in Decree 98/2021/NĐ-CP regulations since 2018. Having successfully cleared 600+ complex medical device licensing and import cases, he ensures bulletproof government compliance.
Strategic operations advisor with extensive McKinsey consulting heritage. Luke coordinates corporate pathway planning, technical gap analysis, and global manufacturer relationships to secure seamless market entry and commercial scaling.
Distinguished medical expert, previously serving as the Head of the Forensic Medicine Center of Hanoi. Dr. Khanh oversees clinical evaluations, technical dossier validity, and official government-level scientific advisory panels.
Hear from companies who successfully entered Vietnam with MedPass.
"MedPass successfully registered our complex Class C active implantable device in just 8 months. Their technical gap analysis prevented multiple queries from the MOH. They are our go-to partner for Vietnam."
"Navigating the transition to Decree 98 was incredibly complex for our Class B diagnostic equipment. MedPass acted as our Local Representative and obtained our license in record time. Highly professional."
"For a major Japanese manufacturer, compliance is non-negotiable. MedPass ensured absolute regulatory compliance for our Class C and D devices, steering us through consular legalization with zero delays."
Schedule a free 30-minute consultation with our regulatory experts. We'll assess your device, outline the pathway, and give you a clear timeline.
Submit your device classification details. Our senior regulatory specialist will analyze your feasibility and send an initial pathway report within 24 business hours.
hello@medpass.vn
+84 28 1234 5678
Ho Chi Minh City, Vietnam