Vietnam Medical Device Registration & Marketing Authorization Holder
Enter Southeast Asia's fastest growing medtech market, growing 9% a year, with over 90% of devices imported. NexorTest delivers end-to-end Vietnam registration under Decree 98/2021: Class A/B/C/D & IVD licensing with the IMDA/MOH, the reference country fast track, independent Marketing Authorization Holder (MAH) representation, CSDT dossiers, and Vietnamese labeling all under one expert roof.
Four Risk Based Device Classes Under Decree 98/2021
The IMDA classifies all medical devices and IVDs into Classes A-D using the 16 ASEAN aligned (AMDD) rules of Circular 05/2022. Your class decides whether you file a Notification or full Marketing Authorization, the documentation, fees, and review timeline.
Class A Devices
Lowest risk devices such as bandages, tongue depressors, examination gloves, and basic surgical instruments. Filed as a Notification (Declaration of Applied Standards) to the Provincial Department of Health.
- Notification Route
- 3-10 Days
- MAC Indefinite
Class B Devices
Low moderate risk devices such as hypodermic needles, suction equipment, and many reusable instruments. Also filed as a Notification to the Provincial Department of Health via the IMDA portal.
- Notification Route
- 1 Week w/ Reference
- DoAS Certificate
Class C Devices
Moderate to high risk devices including ventilators, hemodialysis machines, contact lenses, and many IVD reagents. Require full Marketing Authorization Registration with the MOH/IMDA and a CSDT dossier.
- Marketing Authorization
- CSDT Required
- Fast Track Eligible
Class D Devices
Highest risk devices such as implantable pacemakers, heart valves, and devices contacting the central nervous system. Subject to the most rigorous MOH/IMDA review and clinical evaluation.
- Full Dossier
- Clinical Evidence
- MAC Indefinite
Choosing the Fastest Route to Your Marketing Authorization
Vietnam offers distinct pathways depending on class and existing approvals. Picking the right route and timing your filing before the 50% fee window closes can cut months and cost off your market entry.
Reference Country Expedited Route
Devices approved by the US FDA, EU (CE/MDR/IVDR), Japan PMDA, Australia TGA, Canada, UK MHRA, Switzerland, China NMPA, or South Korea MFDS qualify for expedited review. The IMDA relies on the reference evaluation rather than re-reviewing raw clinical data the fastest way to a Class C/D Marketing Authorization.
Class A & B Declaration Route
Class A and B devices are filed as a Declaration of Applied Standards to the Provincial Department of Health via the IMDA portal. Approval is typically issued within days, and with reference-country approval the receipt can come in about a week letting you import and sell quickly.
Full Technical Review Route
For Class C/D devices without reference country approval, a complete CSDT technical review is required, including clinical evaluation. We design the dossier and evidence strategy to pass first time and minimize the deficiency cycles that stall Vietnam’s transition-period backlog.
Comprehensive Vietnam Regulatory Services
From classification and MAH representation through post-market vigilance, NexorTest manages every aspect of your Vietnam registration and Marketing Authorization lifecycle.
Medical Device Registration
Complete Marketing Authorization Code (MAC) and Circulation Registration Certificate for Class A, B, C, and D devices and IVDs. We manage classification, dossier preparation, the correct route, fee payment, and query resolution end to end.
Independent MAH / Authorized Rep
Independent Marketing Authorization Holder and Local Authorized Representative services. NexorTest holds your registration neutrally, issues Letters of Authorization to your importers, and because Vietnam bans license transfers lets you switch distributors freely without re-registering.
Reference Country Fast Track
We convert your existing FDA, CE, PMDA, TGA, Health Canada, MHRA, NMPA, or MFDS approval into Vietnam's expedited pathway, removing the full technical review where eligible and shaving several months off your Class C/D timeline.
Device Classification & Strategy
We classify your device under the 16 AMDD rules of Circular 05/2022 and define the Notification vs Marketing Authorization route the decision that determines your dossier scope, fees, and timeline, and prevents costly reclassification penalties.
CSDT Dossier Preparation
End-to-end ASEAN Common Submission Dossier Template (CSDT) compilation for Class C and D, mandatory since January 2024. We map your ISO 13485 system and technical evidence to IMDA expectations and prevent the file-structure gaps that trigger rejections.
Vietnamese Labeling & Legalization
Vietnamese language labeling and IFU per Decree 98 and Decree 111/2021, plus certified translation and consular legalization of your Certificate of Free Sale and Power of Attorney preventing the document mismatches that are a top cause of rejection.
IVD Registration Vietnam
In Vitro Diagnostic registration across all classes. Many reagents and analyzers fall in Class C and D requiring Marketing Authorization and performance evidence. We handle classification, analytical and clinical performance data, reagent documentation, and CSDT.
SaMD & AI/ML Devices
Software is explicitly a medical device under Decree 98. We classify standalone SaMD and AI/ML products by risk, manage software lifecycle and validation evidence, and leverage existing FDA/CE approvals through the reference-country route for faster Vietnam entry.
Post-Market, Price Declaration & Changes
Post-market vigilance and adverse event reporting, price declaration on the MOH portal where required, change notifications, and Circular 57/2025 procurement group positioning keeping your indefinitely valid registration compliant and tender-ready.
Vietnam's Trusted IMDA Specialist
We combine a Vietnam based regulatory team with reference country fast track expertise to deliver faster, more predictable IMDA registrations and independent MAH representation that keeps you in control.
Vietnam Based Regulatory Team
Local regulatory professionals who know the IMDA portal, the Provincial Departments of Health, and the transition period backlog first hand not an offshore desk learning the system from a distance.
Current to the Latest Decrees
We follow Decree 98/2021, as amended by Decree 07/2023 and Decree 04/2025 and consolidated in Document 08/VBHN BYT
Independent MAH You Keep Control
Because Vietnam bans license transfers, tying your registration to a distributor is risky. We hold it as a neutral MAH so you can switch or add importers anytime without re-registering.
One Partner for ASEAN & Global Access
Coordinate Vietnam alongside Thailand, Singapore, Malaysia, Indonesia, US FDA, and EU MDR/CE turning one CSDT into multi-market ASEAN access.
Transparent Fixed Fee Packages
Our fixed fee scopes cover strategy, MAH, CSDT, IMDA submission, and post market support, with clear milestones and deliverables.
Six Steps to Your Marketing Authorization
A proven, structured approach that minimizes IMDA deficiencies and accelerates your path to a Marketing Authorization Code.
Classification & Pathway Strategy
We confirm your risk class (A, B, C or D) using the 16 AMDD rules of Circular 05/2022, choose the Notification or Marketing Authorization route, and determine whether the reference country fast track applies.
Appoint MAH / Authorized Rep
NexorTest is appointed as your independent Vietnam based Marketing Authorization Holder, holding the required Establishment License and ready to submit and hold your registration neutrally on your behalf.
ISO 13485
We verify a valid ISO 13485 certificate covering the specific device and site with sufficient remaining validity a mandatory prerequisite the IMDA checks before opening any application.
CSDT Dossier & Legalization
We compile the legalized Power of Attorney and Certificate of Free Sale, ISO 13485 certificate, CSDT technical summary, clinical evidence where required, and Vietnamese language labeling and IFU with certified translation.
IMDA Submission & Query Management
We submit through the IMDA online portal to the Provincial Department of Health or MOH, pay government fees, and resolve every request for modification quickly to avoid the five-round rejection limit.
MAC, Labeling & Post-Market Surveillance
You receive your indefinitely valid Marketing Authorization Code. We finalize Vietnamese labeling, complete price declaration where required, and set up vigilance, change notifications, and distributor Letters of Authorization.
IMDA Expertise Across Every Device Category
From implantables to AI driven digital health, our regulatory specialists cover the full breadth of medical technology entering the Vietnam market.
- 🫀 Cardiovascular & Implants
- 🧬 In Vitro Diagnostics
- 🤖 AI/ML Diagnostics
- 💻 SaMD & Digital Health
- 🩻 Imaging & Radiology
- 🦴 Orthopaedics
- 💉 Infusion & Drug Delivery
- 🩸 Surgical Instruments
- 👁 Ophthalmics & Contact Lenses
- 🦷 Dental Devices
- 🏥 Hemodialysis & Ventilation
- 📱 Wearables & Remote Monitoring
Frequently Asked Questions for Medical Device Registration Vietnam
What is medical device registration in Vietnam?
Vietnam registration is the mandatory market authorization required before a device or IVD can be imported or sold. It is governed by Decree 98/2021/ND-CP, amended by Decree 07/2023 and 04/2025 and consolidated in Document 08/VBHN-BYT (March 2026). The regulator is the IMDA (renamed from DMEC in January 2025) under the MOH. Class A and B file a Notification to the Provincial Department of Health; Class C and D require Marketing Authorization with the MOH/IMDA. On approval the device receives a Marketing Authorization Code (MAC) valid indefinitely. A Vietnam based MAH and valid ISO 13485 are mandatory.
Do I need a local representative (MAH)?
Yes. Foreign manufacturers must appoint a Vietnam-based Marketing Authorization Holder (MAH) / Local Authorized Representative holding a valid Establishment License. The MAH submits via the IMDA portal, holds the registration, is the MOH’s legal contact, issues Letters of Authorization to importers, and carries post-market duties. Because Vietnam does not allow license transfers, tying your registration to one distributor is risky. NexorTest provides independent MAH services so you can switch distributors freely without re-registering.
What are the device classes in Vietnam?
Vietnam uses a four tier, ASEAN aligned (AMDD) system set out in the 16 rules of Circular 05/2022. Class A is low risk (bandages, gloves), Class B low-moderate (needles, suction), Class C moderate high (ventilators, hemodialysis, contact lenses, many IVD reagents), and Class D high risk (pacemakers, heart valves, CNS contacting devices). Class A/B use a Notification; Class C/D require full Marketing Authorization and a CSDT dossier. Under Decree 98, the MAH classifies the device as part of the application. Software is treated as a device.
Is there a reference country fast track?
Yes, Class C/D devices already approved in a recognized reference country USA (FDA), EU (CE), Japan (PMDA), Australia (TGA), Canada, UK (MHRA), Switzerland, China (NMPA), or South Korea (MFDS) qualify for expedited review. With a valid Free Sale Certificate, the IMDA relies on the reference regulator’s evaluation instead of re-reviewing raw clinical data, often removing the full technical review and shaving several months off the timeline. You still file a complete CSDT dossier. For Class A/B, reference approval can take notification to approval in about a week.
How long does registration take?
Class A/B notifications are typically processed in about 3-10 working days (around a week with reference country approval). For Class C/D, the fast track route runs roughly 10-20 working days of review, while the standard full technical review can take many months given the IMDA’s transition backlog. Realistically, budget 2-6 months end to end including dossier prep, CSDT, and legalization. Completeness is the biggest driver: applications failing after five modification rounds or 90 days without response are rejected, so our pre-submission QC is built to prevent deficiency cycles.
What documents are required?
Typically a legalized Power of Attorney appointing the MAH a legalized Certificate of Free Sale (CFS) from the origin or reference country a valid ISO 13485 certificate covering the specific device and site the classification result; the CSDT technical summary Vietnamese language IFU and labeling a catalogue a Warranty Certificate for non-single use devices and a clinical evaluation summary for Class C/D. Measuring instruments need additional sample approval and calibration. CSDT has been required for Class C/D since January 2024. We compile, translate, legalize and QC the full dossier.
Do Vietnam registrations expire?
No, Under Decree 98, Marketing Authorization Codes for all classes are valid indefinitely with no renewal a major improvement over the old 5 year system. Registrations granted under the older Decree 36/2016 also remain valid. The only exception is emergency procedure registrations, which carry limited validity. While the registration itself does not expire, your ISO 13485 must stay current, post-market vigilance continues, and change notifications must be filed when device details change. NexorTest manages this lifecycle so your registration stays compliant.
Ready to Enter the Vietnam Medical Device Market?
Book a free Vietnam regulatory assessment with our IMDA and MOH experts. We’ll assess your device, identify the appropriate registration pathway, and guide you through the process of obtaining a Marketing Authorization Code.