Vietnam Medical Device Regulations

Agency

All medical devices are regulated by Department of Medical Equipment and Health Works (DMEHW) under the Ministry of Health (MOH)

Medical Device Definition

Medical equipment is the type of equipment, tools, materials and chemicals, necessary software, used alone or in combination with each other to serve the who aims to:

The prevention, examination, diagnosis, treatment, mitigation or illness offset damage
Check, replacement, modification, surgical support during examinations treatment
support or sustain life
control of conception
sterilization of health care (not including chemicals, pesticides, and disinfectants used in household and health)

Classification of Medical Device

No classification system for medical devices in Vietnam

Premarket Approval Process

Appoint a local authorized representative in Vietnam

Submit application for importation. This includes: description of purpose for importation, quality certificate, and Certificate of Free Sale (FSC), and technical requirements (manual, description, list of other countries in which device is approved, safety information)

Submit application dossier. This includes: application form, proof of compliance with ISO 13485, instruction manuals (original and in vietnamese), and Certificate of Free Sale (FSC). Documents must be submitted in the order stated in Appendix 5 in the Device Import Guide

Clinical trial requirement: DMEHW will generally accept foreign clinical trials if device is registered in country of origin

If clinical trials not required

If clinical trials are required: Investigator must prepare protocol. Application will be examined and trial will be be performed

DMEHW will review application and grant import license.

Expected Time:
Within 30 days application will be examined. If clinical trials not required then import license will be granted in ~15 days.
Clinical Trial Timeline: 3-12 months
15 days

Postmarket Surveillance

Â Importers shall annually send reports on the import of medical devices

Notes

The validity duration of an import license is one year
Application for importation: importer must provide a certificate of free sale or confirmation allowing circulation from the: USA or EU
Cost: Very low. Registration fee ~USD $19. Import permit: USD $30-$180 depending on equipment cost

Obtain approval in

Vietnam

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