Vietnam Regulatory Approval Process for Medical and IVD Devices

The Department of Medical Equipment and Construction (DMEC) under the Ministry of Health (MoH) regulates medical devices and in vitro diagnostic (IVD) devices in Vietnam. The Vietnamese system is currently in transition. Presently, all Class A and B devices and some Class C and D devices require marketing authorization to enter the market, while some Class C and D devices are exempt from regulatory oversight until Jan. 1, 2025. Marketing authorization is provided as a Marketing Authorization Code (MAC). 

The Vietnamese DMEC medical device approval process explained

Step 1
Determine the classification of your device according to the DMEC’s classification rules.  

Step 2
Appoint a local representative known as a marketing authorization holder (MAH) to manage your medical device registration and interact with the regulatory authorities on your behalf.  

Step 3
Prepare the application dossier with the necessary documents and formatting associated with your device’s registration route (depending on device classification).   

Step 4
Your MAH submits the application to the MoH or to the local Department of Health, where the MAH is established (depending on device classification) and pays necessary fees.   

Step 5
The MoH or the local Department of Health reviews the application and may request additional information. 

Step 6
Upon approval, the MoH or the local Department of Health issues a receipt note with the new MAC and publishes the details online.