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Vietnam Medical Device Registration

Ministry of Health - Department of Medical Equipment and Health Works (MOH-DMEHW) approval timelines and requirements

1-2 weeks

Typical Timeline

Device Classes

MDSAP Accepted

Required

Vietnam Local Agent

Vietnam Medical Device Registration Overview

Vietnam medical device registration through MOH-DMEHW typically takes 1-2 weeks for Class 1 devices. The official MOH-DMEHW target is 1-2 weeks, but realistic timelines include preparation, documentation review, and potential questions from regulators.Vietnam uses a 4-class (1, 2, 3, 4) risk-based classification system. Foreign manufacturers must appoint a Vietnam Local Agent to register devices in Vietnam. Registration is valid for 5 years.

Registration Timeline by Device Class

Vietnam uses a 4-class (1, 2, 3, 4) risk-based classification system.

Class 1

Notification

Low Risk

Official

1-2 weeks

Realistic

1-2 weeks

• Notification-based, minimal documentation

Class 2

Notification

Medium Risk

Official

1-2 weeks

Realistic

1-2 weeks

• Notification-based

GMP/QMS Required

Class 3

Registration

High Risk

Official

1-1.5 years

Realistic

4-5 months

With Prior Approval

4-5 months

Accelerated with: FDA, TGA, MHLW, EU, MHRA, Swissmedic, NMPA, MFDS

• 12-18+ months without reference country approval

• 4-5 months with reference country approval

GMP/QMS Required

Class 4

Registration

Highest Risk

Official

1-1.5 years

Realistic

4-5 months

With Prior Approval

4-5 months

Accelerated with: FDA, TGA, MHLW, EU, MHRA, Swissmedic, NMPA, MFDS

• 12-18+ months without reference country approval

• 4-5 months with reference country approval

Clinical Trial RequiredGMP/QMS Required

Expedited Pathways

ASEAN CSDT

Common Submission Dossier Template for ASEAN region

20-30% faster

Eligibility: ASEAN member state registrations

Prior Approval Recognition

Existing approvals from other regulatory authorities can accelerate your Vietnam registration.

FDA 510(k)

Documentation support

1-3 months

EU CE Mark

Documentation support

1-3 months

ASEAN MRA

Harmonized pathway

2-3 months

Key Requirements

Vietnam Local Agent
Vietnamese labeling
ISO 13485 certification
Free Sale Certificate
Technical documentation

Registration Validity:

5 years

Registration Process Flowchart

Vietnam Medical Device Registration Process

Step-by-step MOH-DMEHW registration process. Total estimated timeline: 1-2 weeks.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by MOH-DMEHW. Appoint a Vietnam Local Agent.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to MOH-DMEHW including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

MOH-DMEHW reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

1-2 weeks

In-depth technical assessment of device safety and performance. MOH-DMEHW may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, MOH-DMEHW issues Vietnam market authorization certificate.

Summary: The Vietnam medical device registration process through Ministry of Health - Department of Medical Equipment and Health Works (MOH-DMEHW) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

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Related Resources

MOH-DMEHW Regulation News Government Registration Fees

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Timelines are estimates based on 2024-2025 data. Last updated: 2026-03-01.