MOH Vietnam Medical Device Registration
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Plan Vietnam medical device and IVD access with the correct local class, product route, eligible applicant, technical evidence and lifecycle controls.
Aligning with Vietnam's MOH Regulations
Vietnam's medical device framework is administered by the Ministry of Health through the Infrastructure and Medical Device Administration (IMDA/VIMDA). Some older English materials use the acronym DMEC; current planning should use the authority's present portal and organizational terminology. The framework is based on Decree 98/2021/ND-CP as amended, including Decree 07/2023/ND-CP and Decree 04/2025/ND-CP. The authority lists current instruments on its official regulations page.
Vietnam device and IVD classification
Medical devices and IVDs are classified from Class A, the lowest risk, through Class D, the highest. Classification is based on ASEAN-style rules addressing intended use, invasiveness, duration, active functions, and the impact of a wrong result or failure. A documented classification and grouping decision is foundational because it determines the market-entry route, dossier, fees, and post-market obligations.
Lower-risk and higher-risk products follow different declaration or authorization processes under the current framework. Because transition measures have changed several times, teams should verify the route in force on the filing date rather than relying on expired import-license extensions or old implementation calendars.
Local applicant and registration dossier
An overseas manufacturer needs an eligible Vietnam-based entity to hold or submit the applicable market authorization and serve as the local regulatory contact. The parties should define access to the technical file, change-control duties, validity and renewal work, complaint handling, vigilance, recalls, and transfer arrangements.
The submission typically draws on the ASEAN Common Submission Dossier Template and includes intended use, classification and grouping, device descriptions, manufacturer and site information, ISO 13485 evidence, authorization documents, labeling and instructions for use, reference approvals or free-sale evidence where applicable, and technical, clinical, or performance evidence proportionate to risk. Vietnamese labeling and locally required information must match the approved device.
Post-market and change control
After market entry, the authorization holder and manufacturer must maintain distribution traceability, complaint handling, adverse-event evaluation, corrective actions, and recall readiness. Changes to the device, manufacturer, site, intended use, software, labeling, or quality system should be assessed before implementation. Use the current VIMDA portal for live notices and services; the former IMDA domain may remain available during the authority's announced portal transition.
Current pathway and launch dependencies
| Workstream | Requirement or decision |
|---|---|
| Classes A/B | Declaration of applied standards under the applicable local authority process |
| Classes C/D | Product registration and applicable technical review |
| Reference evidence | Assess an eligible route; foreign authorization is not a universal local licence |
| Transition | Verify the current instrument and product history; do not rely on expired import extensions |
Use the current Ministry/VIMDA procedure and delegated authority applicable to the filing date. Decree 98/2021 as amended remains a core reference, but portal, delegation and transition provisions must be assessed together. Keep the locally authorized product, Vietnamese labels/IFU, manufacturing sites and importer arrangements aligned.
Use the official Ministry of Health / VIMDA instructions for the precise category, forms, fees and supporting records. Maintain a product-level plan covering evidence gaps, local permissions, filing, authority questions and release. Government charges, certification/audit, translations and service fees are separate; avoid undated currency conversions or a guaranteed approval date. Connect the plan to the market's classification, labeling and postmarket guides below.
Regulatory Update · Sep 5, 2026Vietnam Inspection Roadmap (TT 24/2026)Case Study · Aug 5, 2026Vietnam IVD Registration for an Oncology AssayRegulatory Update · Mar 10, 2026Vietnam 2026 Medical Device Labeling RequirementsRegulatory Update · Jul 9, 2025Vietnam MoH Reduces Medical Device Registration Fees by 50% Through 2026Blog · Nov 9, 2026Classification across four marketsVideo · Oct 16, 2026Vietnam IMDA: Device Classes and RegistrationVideo · Aug 11, 2025How to register a medical device in VietnamRegulatory Update · Nov 6, 2026Thai device change timelinesBlog · Nov 2, 2026Five-market device change controlBlog · Oct 5, 2026China GMP inspection preparation
Faster submissions. Predictable costs. Local support.
We provide turnkey regulatory support in Vietnam, all for a flat annual fee:
Dossier preparation and submission, powered by AI assisted workflows and regulatory experts.
In country representation, with Pure Global serving as your Marketing Authorization Holder (MAH).
Post market surveillance support, including vigilance reporting and authority communications.
Importer authorizations, post approval modifications, and renewals.
Frequently asked questions
No. It may support an eligible evidence or evaluation route, but local classification, applicant permissions, product authorization, labeling and lifecycle requirements still apply. Document the specific route and its conditions.
No. Confirm the local company’s permitted activities and the device’s registration, declaration, listing or licence separately. A product record does not automatically authorize every importer or distributor.
Identify the actual route and current official charges, then separately budget evidence, certifications, translation and local services. Separate authority processing from applicant responses and prerequisite work rather than using one universal calendar promise.
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