Where to Apply for Class C Medical Device Registration with Vietnam MOH?

To register a Class C medical device in Vietnam, you must submit your application through the Vietnam Ministry of Health (MOH) - Department of Medical Equipment and Construction (DMEC) Portal.

1. Online Submission Portal

Vietnam MOH DMEC Portal:
🔗 https://dmec.moh.gov.vn

• The DMEC portal is the official online platform for medical device registration in Vietnam.

• All applications, including Class C medical device registrations, must be submitted via this portal.

2. Who Can Submit?

• Only a Local Authorized Representative (LAR) in Vietnam can apply.

• Foreign manufacturers must appoint a Vietnam-based company with the necessary legal registration to act as the LAR.

3. Submission Process

Step 1: Register on DMEC Portal

• The LAR must create an account on the DMEC portal and receive login credentials.

Step 2: Prepare & Upload Documents

• Submit the registration dossier including legal, administrative, and technical documentation.

• Pay the registration fee via the portal.

Step 3: MOH Review & Approval

• MOH will review the application within 10 to 90 days (though delays can occur).

• If approved, a Marketing Authorization (MA) number will be issued.

Need Help with Registration?

Would you like guidance on dossier preparation, LAR selection, or compliance requirements? 😊

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn