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 |
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