Regulatory Authority
Department of Medical Equipment and Construction of the Ministry of Health.
Classification
Class A (minimal risk), Class B (low risk), Class C (high risk), Class D (very high risk).
To be placed on the Vietnamese market, Class A and B Medical Devices require notification to the Health Service Department to obtain a Notification of Applicable Standard.
Class C and D Medical Devices require registration with the Department of Medical Equipment and Construction of the Ministry of Health (MOH) to obtain a Circulation Registration Certificate/Product Licence.
Manufacturers of Medical Devices must appoint a Local Representative to handle notifications, device registrations and post-market surveillance.
Applicant
A Local Representative is needed in Vietnam.
Timeframe and costs
For Class A and B Devices 7 – 10 days for review.
For Class C and D devices, review takes 6 – 12 months.
Costs depend on the Risk Class: the higher the Risk Class of the Device, the higher the cost for its revision (from a maximum of 216 US$ for Risk Class D to a minimum of 43 US$ for Risk Class A).
Validity
Notification of Applicable Standard and Circulation Registration Certificate have unlimited validity.
Documentation Language and Labelling
The necessary Application and Labelling Dossier must be provided in Vietnamese.
Useful information
Class A and B Devices (it is not yet official for Class C and D Devices) approved by at least one of the following countries: USA, Canada, Europe, Japan, Australia, China or Korea are not subject to a full technical dossier evaluation.
