vietnam

Regulatory Authority

Department of Medical Equipment and Construction of the Ministry of Health.

Classification of Medical Devices and IVDs

Class A (minimal risk), Class B (low risk), Class C (high risk), Class D (very high risk).

Medical Device Registration in Vietnam

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.

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