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The DMEC Portal (National Medical Device Information System)

The National Medical Device Information System — DMEC (Hệ thống Thông tin Quản lý Trang thiết bị Y tế) at dmec.gov.vn is the central online platform for all medical device regulatory interactions with DAV and provincial health departments in Vietnam.

What can you do in DMEC?​

DMEC supports the full regulatory lifecycle:

ActivityDMEC function
Type A & B DeclarationSubmit and manage Công bố submissions
Type C & D RegistrationSubmit and manage Đăng ký lưu hành applications
Import permit applicationApply for Giấy phép nhập khẩu
Post-market reportingSubmit adverse incident reports and FSCA notifications
Change notificationSubmit notifications of changes to declared/registered devices
Status trackingTrack application status and view issued authorisation numbers

Setting up a DMEC account​

  1. Visit dmec.gov.vn
  2. Select "Đăng ký tài khoản" (Register account)
  3. Enter the Vietnamese company's Business Registration Number, tax code, and contact details
  4. Verify the account via email
  5. Log in and complete the company profile

Foreign manufacturers cannot create a DMEC account directly — the account is created by and in the name of the Vietnamese Authorised Representative.

Submitting a declaration (Type A/B)​

  1. Log in and navigate to "Công bố trang thiết bị y tế"
  2. Select "Tạo mới" (Create new)
  3. Enter device details: name, model, intended purpose, manufacturer information, classification
  4. Upload required documents (see Declaration Type A/B)
  5. Review and submit
  6. Download the receipt/declaration number

Submitting a registration application (Type C/D)​

  1. Log in and navigate to "Đăng ký lưu hành"
  2. Select "Tạo mới" (Create new)
  3. Complete the device information form
  4. Upload dossier modules (CSDT format)
  5. Pay the applicable government fee (bank transfer confirmation required)
  6. Submit and note the application reference number
  7. Monitor status — DAV will notify you of RAIs or approval through the system

Tracking your application​

Use the dashboard to:

  • View current status of all pending applications
  • Download issued certificates and authorisation numbers
  • Respond to DAV requests for additional information
  • Receive system notifications

Common DMEC issues​

  • Browser compatibility: DMEC works best with Google Chrome; some features may not function correctly in other browsers
  • Document upload limits: Dossier modules have individual file size limits — split large files and use compressed PDFs
  • Language: DMEC is primarily in Vietnamese; consider engaging a Vietnamese-speaking regulatory specialist for initial account setup
note

DMEC is actively developed and updated by MOH. The interface and features may change as the system evolves. Always check the official dmec.gov.vn for the current version.