MOH Vietnam Medical Device Registration
Last reviewed:
Medical devices and IVDs sold in Vietnam must be registered with the IMDA, Vietnam's medical device regulatory. The Vietnam device registration process involves notification of Class A devices or submitting a technical dossier for Class B, C, and D devices. All foreign manufacturers needs an in-country representative.
Pure Global simplifies the process with AI workflows that accelerate submission preparation, along with local support and representation, all for a flat annual fee.
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.
Regulatory Update · Mar 10, 2026Vietnam 2026 Medical Device Labeling RequirementsRegulatory Update · Jul 9, 2025Vietnam MoH Reduces Medical Device Registration Fees by 50% Through 2026Video · Aug 11, 2025How to register a medical device in VietnamRegulatory Update · Jul 21, 2026Malaysia MDA Online Product ClassificationRegulatory Update · Jul 7, 2026Malaysia MeDC@St Automated Re-Registration 2026Research Report · Aug 3, 2026ISO 10993-1:2025: One Core, Seven Regulatory SystemsResearch Report · Jul 27, 2026IVD Global Market Access 2026Research Report · Jul 20, 2026Orthopedic Implants: The 2026 Global Market-Access MapResearch Report · Jul 13, 2026Aesthetic Devices: The 2026 Global Market-Access MapVideo · Aug 25, 2025How to register a medical device in the Philippines
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
Vietnam charges mandatory government fees for medical device registration based on device risk class, with fees assessed per product.
Application fees are as follows:
- Class A: VND 500,000 (approximately USD 20) per product
- Class B: VND 1,500,000 (approximately USD 60) per product
- Class C: VND 3,000,000 (approximately USD 120) per product
- Class D: VND 3,000,000 (approximately USD 120) per product
All fees listed are government fees only and do not include consulting services, dossier preparation, translations, local registration holder services, or regulatory representation. Fees may change without notice.
Check our Fee Calculator for up-to-date government fees in 14 markets.
Pure Global offers flat-fee annual pricing for bundled medical device and IVD registration and representation in Vietnam, starting at $2,000/year. The flat fee includes dossier preparation and submission, in-country representation, translation, modifications, distributor authorization, and post-market support. The fee does not include government fees, certified translations, or translations from languages other than English.
Flat fee structure for medical devices and IVDs:
1 device = $2,000/year
2-10 devices = additional $500 per device per year (e.g., 7 devices = $5,000/year)
Contact us for a custom quote if you have 11+ devices.
A three-year contract is required to lock in the fees quoted above. However, other contractual arrangements are available. Use our Fee Calculator for an instant estimate and more information about flat fee terms.
Medical devices in Vietnam are categorized into four classes (A to D) based on their risk level, with Class A representing the lowest risk and Class D the highest. This Vietnam medical device classification determines the regulatory pathway and specific requirements for market entry. They oversee the compliance and regulatory requirements for market entry.
Foreign manufacturers need an eligible Vietnam-based authorization holder or applicant for regulatory submissions and local lifecycle responsibilities. The parties must confirm the current VIMDA route by class, prepare the applicable technical dossier or declaration, and maintain labeling, change-control, vigilance, and recall responsibilities after market entry.
The Marketing Authorization Holder (MAH) acts as the representative for foreign manufacturers in regulatory submissions and interactions with the Vietnamese authorities. The MAH ensures that the necessary documentation and compliance requirements are met for Vietnam medical device registration and market entry of medical devices in Vietnam.
Single Process,
Multiple Markets
When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
Let's Talk,
Anywhere You Are.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
Contact us