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, necessarysoftware, used alone or in combination with each other to serve the who aims to:
  1. The prevention, examination, diagnosis, treatment, mitigation or illness offset damage
  2. Check, replacement, modification, surgical support during examinations treatment
  3. support or sustain life
  4. control of conception
  5. 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
 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
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